Single Use Electrosurgical Knife KD-620LR (UDI 04953170208409)Recalls & reported problems

Summary

The FDA's MAUDE database contains 48 adverse event reports that list this exact device (DI 04953170208409), received between Jun 21, 2018 and Aug 22, 2024 — classified as 1 death, 42 injuries, 5 malfunctions.

The most frequently reported specific device problem is “Break” (8 reports).

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 48 reports, in the reporter's own words as published by the FDA.

• InjuryAug 22, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  OLYMPUS REVIEWED THE FOLLOWING LITERATURE TITLED "EFFICACY AND SAFETY OF MC-003 SOLUTION FOR ENDOSCOPIC MUCOSAL OR SUBMUCOSAL RESECTION: A PROSPECTIVE, MULTICENTER, RANDOMIZED, TRIPLE-BLINDED, PARALLEL-GROUP, PHASE III STUDY." BACKGROUND AND AIMS: THE SAFETY AND EFFICACY OF SOLUTIONS FOR SUBMUCOSAL INJECTION ARE CRITICAL FOR ENDOSCOPIC RESECTION OF GASTRIC ADENOMAS OR EARLY GASTRIC CANCERS. ALTHOUGH SEVERAL INJECTABLE SOLUTIONS HAVE BEEN INTRODUCED FOR ENDOSCOPIC RESECTION, THEY HAVE SOME LIMITATIONS. WE AIMED TO COMPARE THE EFFICACY OF THE NEW SODIUM ALGINATE¿BASED SOLUTION MC-003 WITH THAT OF NORMAL SALINE (NS; 0.9% SODIUM CHLORIDE). METHODS: IN THIS RANDOMIZED, TRIPLE-BLIND STUDY, 70 PATIENTS WERE INITIALLY ENROLLED FOR EMR OR ENDOSCOPIC SUBMUCOSAL DISSECTION (ESD). THE MAIN OUTCOMES INCLUDED THE NEED FOR ADDITIONAL INJECTIONS, COMPLETION OF EN BLOC RESECTION, AND OCCURRENCE OF ADVERSE EVENTS. RESULTS: EACH GROUP ULTIMATELY INCLUDED 34 PATIENTS. COMPLETE EN BLOC RESECTIONS WERE ACHIEVED IN ALL PATIENTS (P Z 1.000). THE MC-003 GROUP HAD MORE PERI-NEOPLASM TISSUE FIBROSIS (P Z .056) AND NEEDED FEWER ADDITIONAL INJECTIONS FOR LESIONS >15 MM (P Z .037), LOCATED IN THE DISTAL PORTION

  Patient problems: Gastrointestinal Hemorrhage

  MAUDE report 20043749 ↗
• InjuryJul 26, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  OLYMPUS MEDICAL SYSTEMS CORP. (OMSC) REVIEWED A LITERATURE TITLED "ENDOSCOPIC RESECTION OF GASTRIC GASTROINTESTINAL STROMAL TUMOR USING CLIP-AND-CUT ENDOSCOPIC FULL-THICKNESS RESECTION: A SINGLE-CENTER, RETROSPECTIVE COHORT IN KOREA". LITERATURE SUMMARY BACKGROUND/AIMS: TO OVERCOME THE TECHNICAL LIMITATIONS OF CLASSIC ENDOSCOPIC RESECTION FOR GASTRIC GASTROINTESTINAL STROMAL TUMORS (GISTS), VARIOUS METHODS HAVE BEEN DEVELOPED. IN THIS STUDY, WE EXAMINED THE ROLE AND FEASIBILITY OF CLIP-AND-CUT PROCEDURES (CLIP-AND-CUT ENDOSCOPIC FULL-THICKNESS RESECTION [CC-EFTR]) FOR GASTRIC GISTS. METHODS: MEDICAL RECORDS OF 83 PATIENTS DIAGNOSED WITH GISTS AFTER ENDOSCOPIC RESECTION BETWEEN 2005 AND 2021 WERE RETROSPECTIVELY REVIEWED. MOREOVER, CLINICAL CHARACTERISTICS AND OUTCOMES WERE ANALYZED. ADVERSE EVENTS A TOTAL OF 43 (51.8%) PATIENTS EXPERIENCED ADVERSE EVENTS AFTER ER (TABLE 5). THE OVERALL RATES OF ADVERSE EVENTS WERE HIGHER IN THE CC-EFTR GROUP COMPARED TO THAT IN THE ESD GROUP (37.3% FOR ESD VS. 75.0% FOR CC-EFTR, P=0.001). PNEUMOPERITONEUM OCCURRED IN 13 (25.5%) AND 22 (68.8%) PATIENTS IN THE ESD AND CC-EFTR GROUPS, RESPECTIVELY. HOWEVER, ONLY ONE PATIENT IN THE ESD GROUP AND TWO IN

  Patient problems: Fever; Peritonitis; Pneumoperitoneum

  MAUDE report 19842262 ↗
• InjuryJul 26, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  OLYMPUS MEDICAL SYSTEMS CORP. (OMSC) REVIEWED A LITERATURE TITLED "ENDOSCOPIC RESECTION OF GASTRIC GASTROINTESTINAL STROMAL TUMOR USING CLIP-AND-CUT ENDOSCOPIC FULL-THICKNESS RESECTION: A SINGLE-CENTER, RETROSPECTIVE COHORT IN KOREA". LITERATURE SUMMARY BACKGROUND/AIMS: TO OVERCOME THE TECHNICAL LIMITATIONS OF CLASSIC ENDOSCOPIC RESECTION FOR GASTRIC GASTROINTESTINAL STROMAL TUMORS (GISTS), VARIOUS METHODS HAVE BEEN DEVELOPED. IN THIS STUDY, WE EXAMINED THE ROLE AND FEASIBILITY OF CLIP-AND-CUT PROCEDURES (CLIP-AND-CUT ENDOSCOPIC FULL-THICKNESS RESECTION [CC-EFTR]) FOR GASTRIC GISTS. METHODS: MEDICAL RECORDS OF 83 PATIENTS DIAGNOSED WITH GISTS AFTER ENDOSCOPIC RESECTION BETWEEN 2005 AND 2021 WERE RETROSPECTIVELY REVIEWED. MOREOVER, CLINICAL CHARACTERISTICS AND OUTCOMES WERE ANALYZED. ADVERSE EVENTS: A TOTAL OF 43 (51.8%) PATIENTS EXPERIENCED ADVERSE EVENTS AFTER ER (TABLE 5). THE OVERALL RATES OF ADVERSE EVENTS WERE HIGHER IN THE CC-EFTR GROUP COMPARED TO THAT IN THE ESD GROUP (37.3% FOR ESD VS. 75.0% FOR CC-EFTR, P=0.001). PNEUMOPERITONEUM OCCURRED IN 13 (25.5%) AND 22 (68.8%) PATIENTS IN THE ESD AND CC-EFTR GROUPS, RESPECTIVELY. HOWEVER, ONLY ONE PATIENT IN THE ESD GROUP AND TWO I

  Patient problems: Perforation

  MAUDE report 19840348 ↗
• InjuryJul 26, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  OLYMPUS MEDICAL SYSTEMS CORP. (OMSC) REVIEWED A LITERATURE TITLED "ENDOSCOPIC RESECTION OF GASTRIC GASTROINTESTINAL STROMAL TUMOR USING CLIP-AND-CUT ENDOSCOPIC FULL-THICKNESS RESECTION: A SINGLE-CENTER, RETROSPECTIVE COHORT IN KOREA". LITERATURE SUMMARY BACKGROUND/AIMS: TO OVERCOME THE TECHNICAL LIMITATIONS OF CLASSIC ENDOSCOPIC RESECTION FOR GASTRIC GASTROINTESTINAL STROMAL TUMORS (GISTS), VARIOUS METHODS HAVE BEEN DEVELOPED. IN THIS STUDY, WE EXAMINED THE ROLE AND FEASIBILITY OF CLIP-AND-CUT PROCEDURES (CLIP-AND-CUT ENDOSCOPIC FULL-THICKNESS RESECTION [CC-EFTR]) FOR GASTRIC GISTS. METHODS: MEDICAL RECORDS OF 83 PATIENTS DIAGNOSED WITH GISTS AFTER ENDOSCOPIC RESECTION BETWEEN 2005 AND 2021 WERE RETROSPECTIVELY REVIEWED. MOREOVER, CLINICAL CHARACTERISTICS AND OUTCOMES WERE ANALYZED. ADVERSE EVENTS A TOTAL OF 43 (51.8%) PATIENTS EXPERIENCED ADVERSE EVENTS AFTER ER (TABLE 5). THE OVERALL RATES OF ADVERSE EVENTS WERE HIGHER IN THE CC-EFTR GROUP COMPARED TO THAT IN THE ESD GROUP (37.3% FOR ESD VS. 75.0% FOR CC-EFTR, P=0.001). PNEUMOPERITONEUM OCCURRED IN 13 (25.5%) AND 22 (68.8%) PATIENTS IN THE ESD AND CC-EFTR GROUPS, RESPECTIVELY. HOWEVER, ONLY ONE PATIENT IN THE ESD GROUP AND TWO IN

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 19838921 ↗
• InjuryJun 3, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  OLYMPUS RECEIVED A LITERATURE TITLED "ENDOSCOPIC RESECTION OF GIANT ESOPHAGEAL SUBEPITHELIAL LESIONS: EXPERIENCE FROM A LARGE TERTIARY CENTER." POSTOPERATIVE ADVERSE EVENTS AFTER ENDOSCOPIC RESECTION OF AN ESOPHAGEAL GIANT SUBEPITHELIAL LESION. A PATIENT (49-YEAR-OLD WOMAN) UNDERWENT A DIFFICULT RESECTION PROCEDURE WITH THE WOUND COVERED BY A METAL STENT. THE POSTOPERATIVE DAY (POD) 2 COMPUTED TOMOGRAPHY (CT) SCAN SHOWED POSTOPERATIVE BILATERAL PLEURAL EFFUSION OF THE PATIENT. POD 8 ENDOSCOPY DETECTED AN ESOPHAGEAL FISTULA. A LARGE ESOPHAGEAL WALL DEFECT WAS FOUND, PURULENT EXUDATES AND A DRAINAGE TUBE PLACED IN THE THORACIC CAVITY COULD BE OBSERVED ENDOSCOPICALLY THROUGH THE FISTULA, AND A GASTRIC TUBE WAS THEN INSERTED INTO THE FISTULA FOR DRAINAGE. THE FISTULA SHRANK SIGNIFICANTLY ON POD 28, WITH PROLIFERATING GRANULATION TISSUE SEEN AT THE SITE. AFTER CHANGING THE GASTRIC TUBE SEVERAL TIMES, THE PATIENT FINALLY RECOVERED AND WAS DISCHARGED ON POD40.

  Patient problems: Fistula; Pleural Effusion

  MAUDE report 19455660 ↗
• InjuryJun 3, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  OLYMPUS RECEIVED A LITERATURE TITLED "ENDOSCOPIC RESECTION OF GIANT ESOPHAGEAL SUBEPITHELIAL LESIONS: EXPERIENCE FROM A LARGE TERTIARY CENTER." BACKGROUND AND AIMS: INCREASED REPORTS ON ENDOSCOPIC RESECTION (ER) OF ESOPHAGEAL GIANT SUBEPITHELIAL LESIONS (G-SELS) HAVE EMERGED IN RECENT YEARS. THE AIM OF THIS STUDY WAS TO EVALUATE THE EFFICACY, TECHNICAL DIFFICULTY, AND SAFETY THROUGH OUR SINGLE-CENTER EXPERIENCE. METHODS: SEVENTY-FIVE PATIENTS WITH G-SELS UNDERGOING ENDOSCOPIC RESECTION WERE INCLUDED IN THE TRAINING SET. CLINICOPATHOLOGIC FEATURES, PROCEDURE-RELATED CHARACTERISTICS, POSTPROCEDURAL OUTCOMES, AND FOLLOW-UP DATA WERE ANALYZED. A PREDICTIVE NOMOGRAM MODEL FOR PROCEDURAL DIFFICULTY WAS PROPOSED BASED ON THE MULTIVARIABLE LOGISTIC REGRESSION ANALYSIS. INTERNAL AND EXTERNAL VALIDATIONS WERE CONDUCTED TO VERIFY THE MODEL PERFORMANCE. RESULTS: THE OVERALL EN BLOC RESECTION RATE WAS 93.3%. INTRAOPERATIVE AND POSTOPERATIVE ADVERSE EVENTS OCCURRED IN 7 (9.3%) AND 13 (17.3%) PATIENTS, RESPECTIVELY. NO RECURRENCE OR METASTASIS WAS OBSERVED. THIRTY-TWO (42.7%) PATIENTS UNDERWENT A DIFFICULT PROCEDURE. AGE (ADJUSTED ODDS RATIO [AOR], .915; P = .004), MAXIMAL TUMOR DIAMETER =8 CM (A

  Patient problems: Fistula; Hemorrhage/Blood Loss/Bleeding; Pneumoperitoneum; Pneumothorax

  MAUDE report 19455586 ↗
• InjuryFeb 28, 2024Break; Detachment of Device or Device Component; Break; Detachment of Device or Device Component

  IT WAS REPORTED WHEN USING A DUAL KNIFE DURING AN ENDOSCOPIC SUBMUCOSAL DISSECTION (ESD) PROCEDURE OF THE BODY OF THE STOMACH, THE TIP WAS DAMAGED AND DROPPED INTO THE BODY. ALL THE FRAGMENTS THAT HAD FALLEN OFF WERE COLLECTED. WHILE SWITCHING TO THE SAME PRODUCT THE KNIFE DID NOT COME OUT HALFWAY. THE DEVICE WAS REPLACED AGAIN AND THE PROCEDURE WAS COMPLETED. THERE WERE NO REPORTS OF PATIENT HARM ASSOCIATED WITH THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18797900 ↗
• InjuryAug 8, 2023Break; Detachment of Device or Device Component; Break; Detachment of Device or Device Component

  A CUSTOMER REPORTED TO OLYMPUS THAT DURING AN ENDOSCOPIC SUBMUCOSAL DISSECTION, THE SINGLE USE ELECTROSURGICAL KNIFE HEAD BROKE OFF WHEN IT WAS USED FOR THE FIRST TIME/TURNED ON AND FELL INTO THE PATIENT'S BODY AND WAS SUBSEQUENTLY REMOVED. IT WAS INITIALLY STATED THAT THE PATIENT WAS NOT ANESTHETIZED BUT THIS WAS UNABLE TO BE CONFIRMED. THE PHYSICIAN FINISHED THE CASE WITH ANOTHER DEVICE OF THE SAME MODEL. THERE WERE NO PATIENT INJURIES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17485002 ↗
• InjuryMay 12, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  OLYMPUS REVIEWED THE FOLLOWING LITERATURE TITLED "USEFULNESS OF THE CLIP-AND-SNARE METHOD USING THE PRE-LOOPING TECHNIQUE FOR ENDOSCOPIC SUBMUCOSAL DISSECTION OF GASTRIC NEOPLASIA: A RANDOMIZED CONTROLLED TRIAL". THIS MULTICENTER, RANDOMIZED CONTROLLED TRIAL AIMED TO ASSESS THE EFFICACY OF CLIP-AND-SNARE METHOD USING THE PRE-LOOPING TECHNIQUE (CSM-PLT) IN GASTRIC ENDOSCOPIC SUBMUCOSAL DISSECTION (ESD). A TOTAL OF 378 PATIENTS WERE FINALLY INCLUDED IN THE PER-PROTOCOL ANALYSIS. THE MEAN PROCEDURE TIMES WERE 69.7 AND 58.0 MIN FOR THE CONVENTIONAL ESD AND CSM-PLT GROUPS, INDICATING THAT THE PROCEDURE WAS SIGNIFICANTLY SHORTER IN THE CSM-PLT GROUP (P=0.009). THE R0 RESECTION RATE TENDED TO BE HIGHER IN THE CSM PLT GROUP THAN IN THE CONVENTIONAL ESD GROUP (P=0.09). THE MEAN PROCEDURE TIME WAS SIGNIFICANTLY SHORTER IN THE NOVICE (P=0.04), TUMOR SIZE =20 MM (P=0.02), AND IT KNIFE (P=0.045) GROUPS. THE MEAN PREPARATION TIME FOR CSM-PLT WAS 2.3 MIN. CSM-PLT METHOD SHORTENED THE ESD PROCEDURE TIME. MOREOVER, CSM-PLT IS SAFE, DOES NOT INCREASE COMPLICATION RATES, AND IS ASSOCIATED WITH BETTER R0 RESECTION RATES THAN CONVENTIONAL ESD. TYPE OF ADVERSE EVENTS/NUMBER OF PATIENTS: PERFORATION - 5.

  Patient problems: Hemorrhage/Blood Loss/Bleeding; Perforation

  MAUDE report 16917942 ↗
• InjuryApr 12, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ADDITIONAL INFORMATION HAS BEEN RECEIVED FOR THIS EVENT FROM THE AUTHORS. THE AUTHORS CONFIRMED NO OLYMPUS EQUIPMENT MALFUNCTIONED DURING ANY OF THE SURGERIES OR PROCEDURES DESCRIBED IN THIS LITERATURE. NO OLYMPUS DEVICE CAUSED OR CONTRIBUTED TO THESE ADVERSE EVENTS IN THIS LITERATURE. NO SERIAL NUMBER OR LOT NUMBER IS AVAILABLE FOR THE OLYMPUS DEVICES USED IN THE PROCEDURE IN THIS STUDY.

  Patient problems: Abdominal Pain; Fever; Perforation; Peritonitis

  MAUDE report 16727900 ↗
• InjuryApr 12, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ADDITIONAL INFORMATION HAS BEEN RECEIVED FOR THIS EVENT FROM THE AUTHORS. THE AUTHORS CONFIRMED NO OLYMPUS EQUIPMENT MALFUNCTIONED DURING ANY OF THE SURGERIES OR PROCEDURES DESCRIBED IN THIS LITERATURE. NO OLYMPUS DEVICE CAUSED OR CONTRIBUTED TO THESE ADVERSE EVENTS IN THIS LITERATURE. NO SERIAL NUMBER OR LOT NUMBER IS AVAILABLE FOR THE OLYMPUS DEVICES USED IN THE PROCEDURE IN THIS STUDY.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 16723469 ↗
• InjuryApr 11, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ADDITIONAL INFORMATION HAS BEEN RECEIVED FOR THIS EVENT FROM THE AUTHORS. THE AUTHORS CONFIRMED NO OLYMPUS EQUIPMENT MALFUNCTIONED DURING ANY OF THE SURGERIES OR PROCEDURES DESCRIBED IN THIS LITERATURE. NO OLYMPUS DEVICE CAUSED OR CONTRIBUTED TO THESE ADVERSE EVENTS IN THIS LITERATURE. NO SERIAL NUMBER OR LOT NUMBER IS AVAILABLE FOR THE OLYMPUS DEVICES USED IN THE PROCEDURE IN THIS STUDY.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 16721429 ↗
• InjuryFeb 8, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  OLYMPUS REVIEWED THE FOLLOWING LITERATURE TITLED "PROPHYLACTIC ANTIBIOTICS MAY BE UNNECESSARY IN GASTRIC ENDOSCOPIC SUBMUCOSAL DISSECTION DUE TO THE LOW INCIDENCE OF BACTEREMIA.". BACKGROUND AND AIMS. ENDOSCOPIC SUBMUCOSAL DISSECTION (ESD) WAS DEVELOPED AS A FEASIBLE AND RELIABLE TREATMENT FOR GASTROINTESTINAL MUCOSAL OR SUBMUCOSAL LESIONS. BACTEREMIA MAY OCCUR AFTER ESD. CURRENTLY, THE USE OF PROPHYLACTIC ANTIBIOTICS AFTER GASTRIC ESD IS CONTROVERSIAL. THIS STUDY WAS DESIGNED TO EXPLORE THE VALUE OF PROPHYLACTIC ANTIBIOTICS IN THE TREATMENT OF GASTRIC MUCOSAL AND SUBMUCOSAL LESIONS AFTER ESD. METHODS: IN THIS PROSPECTIVE STUDY, IN TOTAL, 103 PATIENTS WHO UNDERWENT GASTRIC ESD WERE INCLUDED, AND THE FREQUENCY OF BACTEREMIA AND CHANGES IN INFLAMMATION-RELATED INDICATORS BEFORE AND AFTER THE PROCEDURE WERE INVESTIGATED. THE PATIENTS DID NOT RECEIVE PROPHYLACTIC ANTIBIOTICS. RESULTS: THE BODY TEMPERATURE (T), WHITE BLOOD CELL COUNT (WBC), AND PROCALCITONIN (PCT) AND C-REACTIVE PROTEIN (CRP) LEVELS DID NOT SIGNIFICANTLY DIFFER BETWEEN THE PERFORATION GROUP (N=40) AND NONPERFORATION GROUP BEFORE GASTRIC ESD (N=63) (ALL P>0.05). THE T, WBC, AND CRP LEVELS (ALL P<0.05) IN THE PATIENTS WIT

  Patient problems: Bacterial Infection

  MAUDE report 16329628 ↗
• InjuryFeb 8, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  OLYMPUS REVIEWED THE FOLLOWING LITERATURE TITLED "PROPHYLACTIC ANTIBIOTICS MAY BE UNNECESSARY IN GASTRIC ENDOSCOPIC SUBMUCOSAL DISSECTION DUE TO THE LOW INCIDENCE OF BACTEREMIA.". BACKGROUND AND AIMS: ENDOSCOPIC SUBMUCOSAL DISSECTION (ESD) WAS DEVELOPED AS A FEASIBLE AND RELIABLE TREATMENT FOR GASTROINTESTINAL MUCOSAL OR SUBMUCOSAL LESIONS. BACTEREMIA MAY OCCUR AFTER ESD. CURRENTLY, THE USE OF PROPHYLACTIC ANTIBIOTICS AFTER GASTRIC ESD IS CONTROVERSIAL. THIS STUDY WAS DESIGNED TO EXPLORE THE VALUE OF PROPHYLACTIC ANTIBIOTICS IN THE TREATMENT OF GASTRIC MUCOSAL AND SUBMUCOSAL LESIONS AFTER ESD. METHODS: IN THIS PROSPECTIVE STUDY, IN TOTAL, 103 PATIENTS WHO UNDERWENT GASTRIC ESD WERE INCLUDED, AND THE FREQUENCY OF BACTEREMIA AND CHANGES IN INFLAMMATION-RELATED INDICATORS BEFORE AND AFTER THE PROCEDURE WERE INVESTIGATED. THE PATIENTS DID NOT RECEIVE PROPHYLACTIC ANTIBIOTICS. RESULTS: THE BODY TEMPERATURE (T), WHITE BLOOD CELL COUNT (WBC), AND PROCALCITONIN (PCT) AND C-REACTIVE PROTEIN (CRP) LEVELS DID NOT SIGNIFICANTLY DIFFER BETWEEN THE PERFORATION GROUP (N=40) AND NONPERFORATION GROUP BEFORE GASTRIC ESD (N=63) (ALL P>0.05). THE T, WBC, AND CRP LEVELS (ALL P<0.05) IN THE PATIENTS WIT

  Patient problems: Fever; Perforation

  MAUDE report 16328182 ↗
• InjuryFeb 8, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  OLYMPUS REVIEWED THE FOLLOWING LITERATURE TITLED "PROPHYLACTIC ANTIBIOTICS MAY BE UNNECESSARY IN GASTRIC ENDOSCOPIC SUBMUCOSAL DISSECTION DUE TO THE LOW INCIDENCE OF BACTEREMIA." BACKGROUND AND AIMS: ENDOSCOPIC SUBMUCOSAL DISSECTION (ESD) WAS DEVELOPED AS A FEASIBLE AND RELIABLE TREATMENT FOR GASTROINTESTINAL MUCOSAL OR SUBMUCOSAL LESIONS. BACTEREMIA MAY OCCUR AFTER ESD. CURRENTLY, THE USE OF PROPHYLACTIC ANTIBIOTICS AFTER GASTRIC ESD IS CONTROVERSIAL. THIS STUDY WAS DESIGNED TO EXPLORE THE VALUE OF PROPHYLACTIC ANTIBIOTICS IN THE TREATMENT OF GASTRIC MUCOSAL AND SUBMUCOSAL LESIONS AFTER ESD. METHODS: IN THIS PROSPECTIVE STUDY, IN TOTAL, 103 PATIENTS WHO UNDERWENT GASTRIC ESD WERE INCLUDED, AND THE FREQUENCY OF BACTEREMIA AND CHANGES IN INFLAMMATION-RELATED INDICATORS BEFORE AND AFTER THE PROCEDURE WERE INVESTIGATED. THE PATIENTS DID NOT RECEIVE PROPHYLACTIC ANTIBIOTICS. RESULTS: THE BODY TEMPERATURE (T), WHITE BLOOD CELL COUNT (WBC), AND PROCALCITONIN (PCT) AND C-REACTIVE PROTEIN (CRP) LEVELS DID NOT SIGNIFICANTLY DIFFER BETWEEN THE PERFORATION GROUP (N = 40) AND NONPERFORATION GROUP BEFORE GASTRIC ESD (N = 63) (ALL P > 0.05). THE T, WBC, AND CRP LEVELS (ALL P < 0.05) IN THE PATIE

  Patient problems: Bacterial Infection; Perforation

  MAUDE report 16325331 ↗
• InjuryFeb 8, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  OLYMPUS REVIEWED THE FOLLOWING LITERATURE TITLED "PROPHYLACTIC ANTIBIOTICS MAY BE UNNECESSARY IN GASTRIC ENDOSCOPIC SUBMUCOSAL DISSECTION DUE TO THE LOW INCIDENCE OF BACTEREMIA." BACKGROUND AND AIMS: ENDOSCOPIC SUBMUCOSAL DISSECTION (ESD) WAS DEVELOPED AS A FEASIBLE AND RELIABLE TREATMENT FOR GASTROINTESTINAL MUCOSAL OR SUBMUCOSAL LESIONS. BACTEREMIA MAY OCCUR AFTER ESD. CURRENTLY, THE USE OF PROPHYLACTIC ANTIBIOTICS AFTER GASTRIC ESD IS CONTROVERSIAL. THIS STUDY WAS DESIGNED TO EXPLORE THE VALUE OF PROPHYLACTIC ANTIBIOTICS IN THE TREATMENT OF GASTRIC MUCOSAL AND SUBMUCOSAL LESIONS AFTER ESD. METHODS: IN THIS PROSPECTIVE STUDY, IN TOTAL, 103 PATIENTS WHO UNDERWENT GASTRIC ESD WERE INCLUDED, AND THE FREQUENCY OF BACTEREMIA AND CHANGES IN INFLAMMATION-RELATED INDICATORS BEFORE AND AFTER THE PROCEDURE WERE INVESTIGATED. THE PATIENTS DID NOT RECEIVE PROPHYLACTIC ANTIBIOTICS. RESULTS: THE BODY TEMPERATURE (T), WHITE BLOOD CELL COUNT (WBC), AND PROCALCITONIN (PCT) AND C-REACTIVE PROTEIN (CRP) LEVELS DID NOT SIGNIFICANTLY DIFFER BETWEEN THE PERFORATION GROUP (N = 40) AND NONPERFORATION GROUP BEFORE GASTRIC ESD (N = 63) (ALL P > 0.05). THE T, WBC, AND CRP LEVELS (ALL P < 0.05) IN THE PATIE

  Patient problems: Bacterial Infection

  MAUDE report 16323595 ↗
• InjuryFeb 8, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  OLYMPUS REVIEWED THE FOLLOWING LITERATURE TITLED "PROPHYLACTIC ANTIBIOTICS MAY BE UNNECESSARY IN GASTRIC ENDOSCOPIC SUBMUCOSAL DISSECTION DUE TO THE LOW INCIDENCE OF BACTEREMIA." BACKGROUND AND AIMS: ENDOSCOPIC SUBMUCOSAL DISSECTION (ESD) WAS DEVELOPED AS A FEASIBLE AND RELIABLE TREATMENT FOR GASTROINTESTINAL MUCOSAL OR SUBMUCOSAL LESIONS. BACTEREMIA MAY OCCUR AFTER ESD. CURRENTLY, THE USE OF PROPHYLACTIC ANTIBIOTICS AFTER GASTRIC ESD IS CONTROVERSIAL. THIS STUDY WAS DESIGNED TO EXPLORE THE VALUE OF PROPHYLACTIC ANTIBIOTICS IN THE TREATMENT OF GASTRIC MUCOSAL AND SUBMUCOSAL LESIONS AFTER ESD. METHODS: IN THIS PROSPECTIVE STUDY, IN TOTAL, 103 PATIENTS WHO UNDERWENT GASTRIC ESD WERE INCLUDED, AND THE FREQUENCY OF BACTEREMIA AND CHANGES IN INFLAMMATION-RELATED INDICATORS BEFORE AND AFTER THE PROCEDURE WERE INVESTIGATED. THE PATIENTS DID NOT RECEIVE PROPHYLACTIC ANTIBIOTICS. RESULTS: THE BODY TEMPERATURE (T), WHITE BLOOD CELL COUNT (WBC), AND PROCALCITONIN (PCT) AND C-REACTIVE PROTEIN (CRP) LEVELS DID NOT SIGNIFICANTLY DIFFER BETWEEN THE PERFORATION GROUP (N = 40) AND NONPERFORATION GROUP BEFORE GASTRIC ESD (N = 63) (ALL P>0.05). THE T, WBC, AND CRP LEVELS (ALL P < 0.05) IN THE PATIENT

  Patient problems: Bacterial Infection

  MAUDE report 16321938 ↗
• InjuryFeb 8, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  OLYMPUS REVIEWED THE FOLLOWING LITERATURE TITLED "PROPHYLACTIC ANTIBIOTICS MAY BE UNNECESSARY IN GASTRIC ENDOSCOPIC SUBMUCOSAL DISSECTION DUE TO THE LOW INCIDENCE OF BACTEREMIA." BACKGROUND AND AIMS: ENDOSCOPIC SUBMUCOSAL DISSECTION (ESD) WAS DEVELOPED AS A FEASIBLE AND RELIABLE TREATMENT FOR GASTROINTESTINAL MUCOSAL OR SUBMUCOSAL LESIONS. BACTEREMIA MAY OCCUR AFTER ESD. CURRENTLY, THE USE OF PROPHYLACTIC ANTIBIOTICS AFTER GASTRIC ESD IS CONTROVERSIAL. THIS STUDY WAS DESIGNED TO EXPLORE THE VALUE OF PROPHYLACTIC ANTIBIOTICS IN THE TREATMENT OF GASTRIC MUCOSAL AND SUBMUCOSAL LESIONS AFTER ESD. METHODS: IN THIS PROSPECTIVE STUDY, IN TOTAL, 103 PATIENTS WHO UNDERWENT GASTRIC ESD WERE INCLUDED, AND THE FREQUENCY OF BACTEREMIA AND CHANGES IN INFLAMMATION-RELATED INDICATORS BEFORE AND AFTER THE PROCEDURE WERE INVESTIGATED. THE PATIENTS DID NOT RECEIVE PROPHYLACTIC ANTIBIOTICS. RESULTS: THE BODY TEMPERATURE (T), WHITE BLOOD CELL COUNT (WBC), AND PROCALCITONIN (PCT) AND C-REACTIVE PROTEIN (CRP) LEVELS DID NOT SIGNIFICANTLY DIFFER BETWEEN THE PERFORATION GROUP (N=40) AND NONPERFORATION GROUP BEFORE GASTRIC ESD (N=63) (ALL P>0.05). THE T, WBC, AND CRP LEVELS (ALL P<0.05) IN THE PATIENTS WITH

  Patient problems: Bacterial Infection; Perforation

  MAUDE report 16321620 ↗
• InjuryFeb 7, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  OLYMPUS REVIEWED THE FOLLOWING LITERATURE TITLED "PROPHYLACTIC ANTIBIOTICS MAY BE UNNECESSARY IN GASTRIC ENDOSCOPIC SUBMUCOSAL DISSECTION DUE TO THE LOW INCIDENCE OF BACTEREMIA.". BACKGROUND AND AIMS ENDOSCOPIC SUBMUCOSAL DISSECTION (ESD) WAS DEVELOPED AS A FEASIBLE AND RELIABLE TREATMENT FOR GASTROINTESTINAL MUCOSAL OR SUBMUCOSAL LESIONS. BACTEREMIA MAY OCCUR AFTER ESD. CURRENTLY, THE USE OF PROPHYLACTIC ANTIBIOTICS AFTER GASTRIC ESD IS CONTROVERSIAL. THIS STUDY WAS DESIGNED TO EXPLORE THE VALUE OF PROPHYLACTIC ANTIBIOTICS IN THE TREATMENT OF GASTRIC MUCOSAL AND SUBMUCOSAL LESIONS AFTER ESD. METHODS IN THIS PROSPECTIVE STUDY, IN TOTAL, 103 PATIENTS WHO UNDERWENT GASTRIC ESD WERE INCLUDED, AND THE FREQUENCY OF BACTEREMIA AND CHANGES IN INFLAMMATION-RELATED INDICATORS BEFORE AND AFTER THE PROCEDURE WERE INVESTIGATED. THE PATIENTS DID NOT RECEIVE PROPHYLACTIC ANTIBIOTICS. RESULTS THE BODY TEMPERATURE (T), WHITE BLOOD CELL COUNT (WBC), AND PROCALCITONIN (PCT) AND C-REACTIVE PROTEIN (CRP) LEVELS DID NOT SIGNIFICANTLY DIFFER BETWEEN THE PERFORATION GROUP (N=40) AND NONPERFORATION GROUP BEFORE GASTRIC ESD (N=63) (ALL P>0.05). THE T, WBC, AND CRP LEVELS (ALL P<0.05) IN THE PATIENTS WITH P

  Patient problems: Bacterial Infection; Fever; Perforation

  MAUDE report 16315864 ↗
• InjuryJan 20, 2023Break; Break

  A CUSTOMER REPORTED TO OLYMPUS THAT DURING COLONOSCOPY AND REMOVAL OF POLYP, USING THIS SINGLE USE LIGATING DEVICE, THE "WIRE CONNECTION" TO THE ENDO LOOP BROKE OFF AT THE HANDLE, SO THAT THE ENDO LOOP COULD NOT BE COMPLETELY RELEASED. THE POLYP PEDICLE WAS CUT BELOW THE ENDO LOOP USING THIS SINGLE USE ELECTROSURGICAL KNIFE. THE BLEEDING IN SEQUENCE WAS STOPPED USING SIX THROUGH-THE-SCOPE (TTS) CLIPS AND 3ML OF PURASTAT GEL. THE PATIENT WAS MONITORED OVERNIGHT, IN THE HOSPITAL, FOR POST OPERATIVE BLEEDING. NO POST OPERATIVE BLEEDING, AS REPORTED. CASE WITH PATIENT IDENTIFIER (B)(6) REPORTS THE SINGLE USE LIGATING DEVICE USED IN THE PROCEDURE. CASE WITH PATIENT IDENTIFIER (B)(6) REPORTS THE SINGLE USE ELECTROSURGICAL KNIFE USED IN THE PROCEDURE.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 16219564 ↗
• InjuryDec 6, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  OLYMPUS REVIEWED THE FOLLOWING LITERATURE TITLED "USEFULNESS OF GENERAL ANESTHESIA MANAGEMENT IN ESOPHAGEAL ESD BY EXPERT AND TRAINEE". TO CLARIFY THE USEFULNESS OF GENERAL ANESTHESIA MANAGEMENT IN ESOPHAGEAL ESD AT INITIATION. TYPE OF ADVERSE EVENTS/NUMBER OF PATIENTS: AMONG THE CASES COMPLETED BY TRAINEE, AS POSTOPERATIVE COMPLICATIONS: PNEUMONIA (0.9%). POSTOPERATIVE BLEEDING (0.9%). THERE IS NO REPORT OF ANY OLYMPUS DEVICE MALFUNCTION IN ANY PROCEDURE DESCRIBED IN THIS STUDY.

  Patient problems: Hemorrhage/Blood Loss/Bleeding; Pneumonia

  MAUDE report 15926356 ↗
• InjuryAug 25, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT IS REPORTED IN THE LITERATURE TITLED ¿PREDICTIVE MODEL FOR BLEEDING AFTER GASTRIC SUBMUCOSAL DISSECTION BEFORE AND AFTER GUIDELINES: A SINGLE-CENTER RETROSPECTIVE STUDY,¿ PATIENTS EXPERIENCED ADVERSE EVENTS AFTER ENDOSCOPIC SUBMUCOSAL DISSECTION PROCEDURES. BACKGROUND: IN JULY 2017, SUPPLEMENTARY GUIDELINES ON ANTICOAGULANTS, INCLUDING DIRECT ORAL ANTICOAGULANTS, WERE PUBLISHED IN JAPAN. WE INVESTIGATED THE CHANGES IN ENDOSCOPIC SUBMUCOSAL DISSECTION (ESD) OF GASTRIC MUCOSAL LESIONS AFTER THE PUBLICATION OF THE SUPPLEMENT, EXAMINED THE RISK FACTORS, AND DEVELOPED A PREDICTIVE MODEL FOR POST-ESD BLEEDING. METHODS: WE INCLUDED 2272 GASTRIC ESD CASES FROM OUR HOSPITAL BETWEEN MAY 2003 AND JUNE 2021 AND CLASSIFIED THEM INTO TWO GROUPS: 1789 CASES BEFORE AND 483 AFTER THE PUBLICATION OF THE SUPPLEMENTARY GUIDELINES. A PREDICTIVE MODEL FOR POST-ESD BLEEDING WAS DEVELOPED USING THE PRE-PUBLICATION COHORT DATA. RESULTS: THE PROPORTION OF PATIENTS RECEIVING WARFARIN DECREASED (5.0% VS. 1.4%) AND THOSE RECEIVING DIRECT ORAL ANTICOAGULANTS INCREASED (1.2% VS. 6.8%) AFTER THE PUBLICATION OF THE SUPPLEMENTARY GUIDELINES. POST-ESD BLEEDING OCCURRED IN 61 PATIENTS, BUT THERE WAS NO SIGNIFICANT

  Patient problems: Hemorrhage/Blood Loss/Bleeding; Perforation; Thromboembolism

  MAUDE report 15294196 ↗
• DeathAug 25, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT IS REPORTED IN THE LITERATURE TITLED ¿PREDICTIVE MODEL FOR BLEEDING AFTER GASTRIC SUBMUCOSAL DISSECTION BEFORE AND AFTER GUIDELINES: A SINGLE-CENTER RETROSPECTIVE STUDY,¿ PATIENTS EXPERIENCED ADVERSE EVENTS AFTER ENDOSCOPIC SUBMUCOSAL DISSECTION PROCEDURES. BACKGROUND: IN JULY 2017, SUPPLEMENTARY GUIDELINES ON ANTICOAGULANTS, INCLUDING DIRECT ORAL ANTICOAGULANTS, WERE PUBLISHED IN JAPAN. WE INVESTIGATED THE CHANGES IN ENDOSCOPIC SUBMUCOSAL DISSECTION (ESD) OF GASTRIC MUCOSAL LESIONS AFTER THE PUBLICATION OF THE SUPPLEMENT, EXAMINED THE RISK FACTORS, AND DEVELOPED A PREDICTIVE MODEL FOR POST-ESD BLEEDING. METHODS: WE INCLUDED 2272 GASTRIC ESD CASES FROM OUR HOSPITAL BETWEEN MAY 2003 AND JUNE 2021 AND CLASSIFIED THEM INTO TWO GROUPS: 1789 CASES BEFORE AND 483 AFTER THE PUBLICATION OF THE SUPPLEMENTARY GUIDELINES. A PREDICTIVE MODEL FOR POST-ESD BLEEDING WAS DEVELOPED USING THE PRE-PUBLICATION COHORT DATA. RESULTS: THE PROPORTION OF PATIENTS RECEIVING WARFARIN DECREASED (5.0% VS. 1.4%) AND THOSE RECEIVING DIRECT ORAL ANTICOAGULANTS INCREASED (1.2% VS. 6.8%) AFTER THE PUBLICATION OF THE SUPPLEMENTARY GUIDELINES. POST-ESD BLEEDING OCCURRED IN 61 PATIENTS, BUT THERE WAS NO SIGNIFICANT

  Patient problems: Insufficient Information

  MAUDE report 15294191 ↗
• InjuryJul 25, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  OLYMPUS REVIEWED THE FOLLOWING LITERATURE: "SECOND-LOOK ENDOSCOPY (SLE) FINDINGS AFTER ENDOSCOPIC SUBMUCOSAL DISSECTION FOR COLORECTAL EPITHELIAL NEOPLASMS." LITERATURE SUMMARY: THIS STUDY AIMED TO INVESTIGATE SLE FINDINGS AND THEIR ROLE IN PREVENTING DELAYED BLEEDING AFTER COLORECTAL ESD. AMONG THE 375 CASES INVESTIGATED, SLES WERE PERFORMED IN 171 (45.6%) PATIENTS. THE INCIDENCES OF HIGH-RISK ULCER STIGMA AND LOW-RISK STIGMA WERE 5.3% (9/171) AND 94.7% (162/171), RESPECTIVELY. DURING SLE, ENDOSCOPIC HEMOSTASIS WAS PERFORMED MORE FREQUENTLY IN THE HIGH-RISK ULCER STIGMA GROUP THAN IN THE LOW RISK ULCER STIGMA GROUP, BUT MOST OF THE ENDOSCOPIC HEMOSTASIS IN THE HIGH-RISK ULCER STIGMA GROUP (3/4, 75.0%) WERE PROPHYLACTIC HEMOSTASIS. POST-ESD DELAYED BLEEDING OCCURRED IN THREE (0.8%) PATIENTS BELONGING TO THE SLE GROUP, OF WHICH, ONE PATIENT WAS FROM THE HIGH-RISK STIGMA GROUP AND TWO WERE FROM THE LOW-RISK STIGMA GROUP. THE INCIDENCE OF HIGH-RISK ULCER STIGMA DURING SLE WAS LOW, AND DELAYED BLEEDING OCCURRED IN, BOTH, HIGH-RISK AND LOW-RISK GROUPS OF SLE. SLES PERFORMED AFTER COLORECTAL ESD MAY NOT BE EFFECTIVE IN PREVENTING DELAYED BLEEDING, AND FURTHER PROSPECTIVE STUDIES ARE NEED

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 15099283 ↗
• InjuryJun 16, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT IS REPORTED IN THE LITERATURE TITLED ¿PREDICTORS OF THE DIFFICULTY FOR ENDOSCOPIC RESECTION OF GASTRIC GASTROINTESTINAL STROMAL TUMOR AND FOLLOW-UP DATA¿, PATIENTS EXPERIENCED ADVERSE EVENTS DURING/AFTER PROCEDURES USING OLYMPUS DEVICES. COMPLAINT WITH PATIENT IDENTIFIER (B)(6) REPORTS KD-611L. COMPLAINT WITH PATIENT IDENTIFIER (B)(6) REPORTS KD-620LR. COMPLAINT WITH PATIENT IDENTIFIER (B)(6) REPORTS GIF-Q260J. COMPLAINT WITH PATIENT IDENTIFIER (B)(6) REPORTS FD-410LR. BACKGROUND/AIM GASTROINTESTINAL STROMAL TUMORS (GISTS) ARE AMONG THE MOST COMMON SUBMUCOSAL TUMORS IN THE STOMACH THAT REQUIRE THERAPEUTIC INTERVENTION. WE AIM TO IDENTIFY THE PREDICTORS OF TECHNICAL DIFFICULTY DURING ENDOSCOPIC RESECTION OF GASTRIC GIST AND TO INVESTIGATE FOLLOW-UP OUTCOMES METHOD PATIENTS WITH GASTRIC GISTS WERE REVIEWED FROM JUNE 2009 TO JUNE 2020 AT ZHONGSHAN HOSPITAL. CLINICAL AND PATHOLOGICAL FEATURES, ENDOSCOPIC PROCEDURE INFORMATION, AND FOLLOW-UP DATA WERE COLLECTED AND ANALYZED. A NOMOGRAM WAS DEVELOPED AND VALIDATED INTERNALLY AND EXTERNALLY. RESULTS: A TOTAL OF 628 GISTS WERE FINALLY ANALYZED. THE DIFFICULTY WAS EXPERIENCED IN 66 CASES. GISTS SIZE (2¿3 CM: OR 2.431 P = 0.018 AND > 3 CM

  Patient problems: Hemorrhage/Blood Loss/Bleeding; Perforation; Pleural Effusion; Unspecified Infection

  MAUDE report 14716124 ↗