Single Use Electrosurgical Knife KD-655 KD-655L (UDI 04953170405624)Recalls & reported problems

Summary

The FDA's MAUDE database contains 38 adverse event reports that list this exact device (DI 04953170405624), received between Mar 28, 2019 and Feb 21, 2025 — classified as 29 injuries, 9 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 38 reports, in the reporter's own words as published by the FDA.

• MalfunctionFeb 21, 2025Fracture; Fracture

  IT WAS OBSERVED DURING THE DEVICE INSPECTION, THAT THE SINGLE USE ELECTROSURGICAL KNIFE WAS BROKEN 0.5MM FROM THE TIP. THERE WERE NO REPORTS OF PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21440089 ↗
• InjuryNov 13, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  OLYMPUS MEDICAL SYSTEMS CORP. (OMSC) RECEIVED A LITERATURE TITLED"SYMPOSIUM 7 (JAPANESE SOCIETY OF GASTROENTEROLOGICAL ENDOSCOPY / JAPANESE SOCIETY OF GASTROENTEROLOGY)". LITERATURE SUMMARY: PURPOSE WITH THE PROGRESS OF HIGH-FREQUENCY DEVICES, EFFECTIVE HEMOSTASIS CAN BE ACHIEVED BY APPLYING ELECTRICITY TO THE TIP OF THE KNIFE DURING GASTRIC ESD SURGERY, AND THERE ARE ALSO MANY CASES WHERE HEMOSTATIC FORCEPS ARE NOT REQUIRED. ON THE OTHER HAND, THE USE OF HEMOSTATIC FORCEPS TO COAGULATE BLOOD VESSELS AS A MEANS OF PREVENTING POST-GASTRIC ESD BLEEDING IS RECOMMENDED IN THE ESD/EMR GUIDELINES. IN THIS CONTEXT, IT IS NOT CLEAR WHETHER TO USE HEMOSTATIC FORCEPS AS A MEANS OF PREVENTING POST-OPERATIVE BLEEDING IN CASES WHERE HEMOSTATIC FORCEPS ARE NOT REQUIRED DURING SURGERY, OR WHETHER IT IS SUFFICIENT TO PREVENT BLEEDING USING THE TIP OF THE KNIFE, SO WE CONDUCTED A RETROSPECTIVE STUDY. [METHODS] PATIENTS WHO UNDERWENT GASTRIC ESD USING THE DUALKNIFE J (OLYMPUS) AT OUR HOSPITAL FROM (B)(6) 2020 TO (B)(6) 2024 WERE INCLUDED IN THE ANALYSIS. IF HAEMOSTATIC FORCEPS WERE USED DURING THE PROCEDURE, IT WAS ASSUMED THAT THE PREVENTION OF BLEEDING WAS CARRIED OUT USING THE HAEMOSTATIC FORCEPS

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 20676901 ↗
• InjuryOct 17, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE FOLLOWING ADDITIONAL INFORMATION WAS RECEIVED FROM THE AUTHOR: AN OLYMPUS DEVICE DID NOT CAUSE OR CONTRIBUTE TO THE ADVERSE EVENT DESCRIBED IN THE ARTICLE. ALSO, IT WAS CONFIRMED THAT AN OLYMPUS DEVICE MALFUNCTION DID NOT OCCUR.

  Patient problems: Dysphagia/ Odynophagia; Hemorrhage/Blood Loss/Bleeding; Swelling/ Edema

  MAUDE report 20472745 ↗
• InjurySep 20, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  OLYMPUS REVIEWED THE FOLLOWING LITERATURE TITLED "SPRAY COAGULATION REDUCES THE USE OF HEMOSTATIC FORCEPS FOR INTRAOPERATIVE BLEEDING IN GASTRIC ENDOSCOPIC SUBMUCOSAL DISSECTION." LITERATURE SUMMARY THIS STUDY RETROSPECTIVELY ASSESSED THE EFFECTIVENESS OF SPRAY MODES ON INTRAOPERATIVE BLEEDING DURING GASTRIC ENDOSCOPIC SUBMUCOSAL DISSECTION (ESD). A TOTAL OF 316 BLEEDING EVENTS (156 IN THE SWIFT GROUP AND 160 IN THE SPRAY GROUP) WERE CONSECUTIVELY RECORDED. IN THE SWIFT GROUP, HEMOSTASIS WAS PERFORMED USING THE SWIFT MODE WITH A RETRACTED TIP OF THE NEEDLE-TYPE KNIFE, FOLLOWED BY THE HEMOSTATIC FORCEPS. IN THE SPRAY GROUP, BLEEDING WAS TREATED IN A STEPWISE MANNER: THE SWIFT MODE, THE SPRAY MODE, AND THE HEMOSTATIC FORCEPS. THE PROCEDURE TIME IN THE SWIFT GROUP AND THE SPRAY GROUP WERE 45 (34¿62) MIN AND 46 (32.5¿61) MIN, RESPECTIVELY. THERE WAS NO SIGNIFICANT DIFFERENCE IN THE TOTAL HEMOSTATIC TIME (SWIFT GROUP, 20 S.; SPRAY GROUP, 16 S.; P = 0.42). IN THE ESD OUTCOMES OF THE SWIFT GROUP AND THE SPRAY GROUP, THE EN BLOC RESECTION RATE (100% VS. 100%), THE R0 RESECTION RATE (100% VS. 97%), AND THE RATE OF CURATIVE RE SECTION (86% VS. 87%) HAD NO SIGNIFICANT DIFFERENCES. DISCUSSION

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 20272882 ↗
• InjuryAug 26, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  OLYMPUS REVIEWED A LITERATURE TITLED "LONG- VS SHORT-SEGMENT BARRETT'S ESOPHAGUS-DERIVED ADENOCARCINOMA: CLINICAL FEATURES AND OUTCOMES OF ENDOSCOPIC SUBMUCOSAL DISSECTION". BACKGROUND THE INCIDENCE OF BARRETT¿S ESOPHAGEAL ADENOCARCINOMA (BEA) IS INCREASING, AND ENDOSCOPIC SUBMUCOSAL DISSECTION (ESD) HAS BEEN FREQUENTLY PERFORMED FOR ITS TREATMENT. HOWEVER, THE DIFFERENCES BETWEEN THE CHARACTERISTICS AND ESD OUTCOMES BETWEEN SHORT- AND LONG-SEGMENT BEA (SSBEA AND LSBEA, RESPECTIVELY) ARE UNCLEAR. WE COMPARED THE CLINICOPATHOLOGICAL CHARACTERISTICS AND SHORT- AND LONG-TERM OUTCOMES OF ESD BETWEEN BOTH GROUPS. METHODS WE RETROSPECTIVELY REVIEWED 155 SUPERFICIAL BEAS (106 SSBEAS AND 49 LSBEAS) TREATED WITH ESD IN 139 PATIENTS AND EXAMINED THEIR CLINICOPATHOLOGICAL FEATURES AND ESD OUTCOMES. SSBEA AND LSBEA WERE CLASSIFIED BASED ON WHETHER THE MAXIMUM LENGTH OF THE BACKGROUND MUCOSA OF BEA WAS < 3 CM OR = 3 CM, RESPECTIVELY. RESULTS COMPARED WITH SSBEA, LSBEA SHOWED SIGNIFICANTLY HIGHER PROPORTIONS OF CASES WITH THE MACROSCOPICALLY FLAT TYPE (36.7% VS. 5.7%, P < 0.001), LEFT WALL LOCATION (38.8% VS. 11.3%, P < 0.001), OVER HALF OF THE TUMOR CIRCUMFERENCE (20.4% VS. 1.9%, P < 0.001), AN

  Patient problems: Stenosis of the esophagus

  MAUDE report 20071938 ↗
• InjuryAug 26, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ALTHOUGH ADDITIONAL INFORMATION WAS REQUESTED, THE AUTHOR REPORTED THAT FURTHER EVENT DETAILS ARE UNKNOWN.

  Patient problems: Bacterial Infection; Chest Pain; Fever; Hemorrhage/Blood Loss/Bleeding; High White Blood Cell Count

  MAUDE report 20065589 ↗
• 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 20040136 ↗
• 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

  Patient problems: Fever; Peritonitis; Pneumoperitoneum

  MAUDE report 19841974 ↗
• 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: Perforation

  MAUDE report 19840165 ↗
• 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 19838835 ↗
• MalfunctionJul 16, 2024Break; Detachment of Device or Device Component; Break; Detachment of Device or Device Component

  IT WAS REPORTED DURING A PROCEDURE, THE PROBE FELL INTO THE PATIENT'S BODY AND WAS RECOVERED, THE DEVICE WAS REPLACED AND THE PROCEDURE WAS COMPLETED. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19756954 ↗
• MalfunctionMay 9, 2024Melted; Detachment of Device or Device Component; Melted; Detachment of Device or Device Component

  IT WAS OBSERVED DURING THE DEVICE INSPECTION, THAT THE SINGLE USE ELECTROSURGICAL KNIFE EXHIBITED INABILITY TO EXTEND AND THE SURFACE OF THE BROKEN PART WAS SCORCHED AND MELTED. THERE WERE NO REPORTS OF PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19275417 ↗
• MalfunctionMar 15, 2024Break; Break

  IT WAS REPORTED, THE ELECTROSURGICAL KNIFE TIP WAS BROKEN AND CAUGHT IN THE DEVICE. THE ISSUE OCCURRED DURING A THERAPEUTIC PROCEDURE (ESD-ENDOSCOPIC SUBMUCOSAL DISSECTION). THE PROCEDURE WAS COMPLETED USING A SIMILAR DEVICE AND THERE WERE NO REPORTS OF PATIENT HARM OR INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18918589 ↗
• InjuryMar 11, 2024Break; Detachment of Device or Device Component; Break; Detachment of Device or Device Component

  IT WAS REPORTED THE TIP OF THE SINGLE USE ELECTROSURGICAL KNIFE DROPPED OFF AND BECAME "INCORPORATED" DURING A THERAPEUTIC ENDOSCOPIC SUBMUCOSAL DISSECTION (ESD) PROCEDURE. THE DROPPED KNIFE TIP WAS COLLECTED WITH A COLLECTION NET. THE PROCEDURE WAS COMPLETED WITH A SIMILAR DEVICE. THERE WAS NO REPORTED PATIENT IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18877020 ↗
• MalfunctionMar 7, 2024Break; Break

  IT WAS REPORTED, THE ELECTROSURGICAL KNIFE TIP DISC FELL OFF DURING AN ESD (ESOPHAGEAL ENDOSCOPIC SUBMUCOSAL DISSECTION) PROCEDURE. THE TIP THAT FELL OFF WAS TOO SMALL TO BE COLLECTED. THE PROCEDURE WAS COMPLETED USING ANOTHER DEVICE. THERE WERE NO REPORTS OF PATIENT HARM OR INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18862584 ↗
• MalfunctionMar 5, 2024Break; Break

  IT WAS REPORTED, THE ELECTROSURGICAL KNIFE BROKE WHEN HIGH FREQUENCY WAS APPLIED SEVERAL TIMES DURING A ESD (ENDOSCOPIC SUBMUCOSAL DISSECTION). THE PROCEDURE WAS COMPLETED AND THERE WERE NO REPORTS OF PATIENT HARM OR INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18838313 ↗
• InjuryFeb 28, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE FOLLOWING ADDITIONAL INFORMATION WAS RECEIVED FROM THE AUTHOR: AN OLYMPUS DEVICE DID NOT CAUSE OR CONTRIBUTE TO THE ADVERSE EVENT DESCRIBED IN THE ARTICLE. ALSO, IT WAS CONFIRMED THAT AN OLYMPUS DEVICE MALFUNCTION DID NOT OCCUR.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 18804333 ↗
• MalfunctionFeb 22, 2024Break; Break

  IT WAS REPORTED, THE ELECTROSURGICAL KNIFE TIP WAS BROKEN AND CAUGHT IN THE DEVICE. THE ISSUE OCCURRED DURING A THERAPEUTIC PROCEDURE (ESD-ENDOSCOPIC SUBMUCOSAL DISSECTION). THE PROCEDURE WAS COMPLETED USING A SIMILAR DEVICE AND THERE WERE NO REPORTS OF PATIENT HARM OR INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18755355 ↗
• InjuryFeb 21, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  OLYMPUS REVIEWED THE FOLLOWING LITERATURE TITLED "OUTCOMES OF ENDOSCOPIC SUBMUCOSAL DISSECTION IN PATIENTS WHO DEVELOP METACHRONOUS SUPERFICIAL ESOPHAGEAL SQUAMOUS CELL CARCINOMA CLOSE TO A POST-ENDOSCOPIC SUBMUCOSAL DISSECTION SCAR". LITERATURE SUMMARY BACKGROUND THE PRESENCE OF POST-ENDOSCOPIC SUBMUCOSAL DISSECTION (ESD) SCARS RENDERS COMPLETE METACHRONOUS SUPERFICIAL ESOPHAGEAL SQUAMOUS CELL CARCINOMA RESECTION DIFFICULT. WE AIMED TO IDENTIFY THE RISK FACTORS FOR INCOMPLETE RESECTION OF METACHRONOUS ESOPHAGEAL SQUAMOUS CELL CARCINOMA CLOSE TO THE POST-ESD SCAR BY ESD. METHODS WE ENROLLED PATIENTS WHO DEVELOPED POST-ESD SUPERFICIAL ESOPHAGEAL SQUAMOUS CELL CARCINOMA AT HIROSHIMA UNIVERSITY HOSPITAL BETWEEN JANUARY 2006 AND MARCH 2020. WE ANALYZED THE OUTCOMES AND RISK FACTORS OF INCOMPLETE RESECTION BETWEEN PATIENTS WHOSE LESIONS WERE CLOSE TO (CLOSE-TO GROUP) AND AWAY FROM (AWAY-FROM GROUP) THE POST-ESD SCAR. PROCEDURE-RELATED PERFORATION WAS IDENTIFIED ENDOSCOPICALLY OR BY THE PRESENCE OF FREE AIR ON A PLAIN CHEST RADIOGRAPH AND CHEST COMPUTED TOMOGRAPHY. ENDOSCOPIC CLIPPING WAS USED TO TREAT INTRAOPERATIVE PERFORATION. BLEEDING DURING ESD WAS DEFINED AS BLEEDING THAT WAS CONTR

  Patient problems: Hemorrhage/Blood Loss/Bleeding; Muscle/Tendon Damage; Perforation; Stenosis

  MAUDE report 18750560 ↗
• InjuryFeb 7, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE FOLLOWING ADDITIONAL INFORMATION WAS RECEIVED FROM THE AUTHOR: AN OLYMPUS DEVICE DID NOT CAUSE OR CONTRIBUTE TO THE ADVERSE EVENT DESCRIBED IN THE ARTICLE. ALSO, IT WAS CONFIRMED THAT AN OLYMPUS DEVICE MALFUNCTION DID NOT OCCUR.

  Patient problems: Hemorrhage/Blood Loss/Bleeding; Perforation

  MAUDE report 18664473 ↗
• MalfunctionJan 17, 2024Break; Break

  THE CUSTOMER REPORTED THE TIP OF THE SINGLE USE ELECTROSURGICAL KNIFE FELL OFF. THE ISSUE OCCURRED DURING A THERAPEUTIC ENDOSCOPIC SUBMUCOSAL DISSECTION (ESD) PROCEDURE. THERE WAS NO REPORTED PATIENT HARM OR IMPACT DUE TO THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18524609 ↗
• InjuryJan 3, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  OLYMPUS REVIEWED THE FOLLOWING LITERATURE TITLED "LONG-TERM OUTCOMES AFTER ENDOSCOPIC SUBMUCOSAL DISSECTION FOR COLORECTAL EPITHELIAL NEOPLASMS IN PATIENTS WITH SEVERE COMORBIDITIES". THE PURPOSE OF THE STUDY WAS TO EXAMINE THESE LONG-TERM OUTCOMES AND COMPARED THEM WITH THOSE IN PATIENTS WITH NON-SEVERE COMORBIDITIES. 231 PATIENTS WITH COLORECTAL EPITHELIAL NEOPLASMS (CENS) UNDERWENT ENDOSCOPIC SUBMUCOSAL DISSECTION (ESD) BETWEEN APRIL 2005 AND MARCH 2023. THE FOLLOWING EVENTS HAVE BEEN REPORTED IN THE LITERATURE FOR ALL 5 PATIENT IDENTIFIERS: EVENT 1: DELAYED BLEEDING (N=4). EVENT 2: PERFORATION (N=11). THIS LITERATURE ARTICLE REQUIRES 5 REPORTS. THE RELATED PATIENT IDENTIFIERS ARE AS FOLLOWS: (B)(6) : KD-655L. (B)(6) : KD-612L. (B)(6) : KD-625LR. (B)(6) : PCF-Q260AZI. (B)(6) : PCF-H290ZI. THIS MEDWATCH REPORT IS FOR PATIENT IDENTIFIER (B)(6), MODEL KD-655L.

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

  MAUDE report 18434731 ↗
• InjuryOct 16, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  OLYMPUS MEDICAL SYSTEMS CORP. (OMSC) RECEIVED A LITERATURE TITLED "SMALL BOWEL ENTRAPMENT AFTER OTSC DEPLOYMENT FOR ENDOSCOPIC CLOSURE OF A COLONIC IATROGENIC PERFORATION". LITERATURE SUMMARY: AN 80 YEAR OLD MAN WAS ADMITTED FOR REMOVAL OF A 35 MM LATERAL SPREADING TUMOR (LST) NON-GRANULAR FLAT ELEVATED TYPE IN THE SIGMOID COLON. AN ENDOSCOPIC SUBMUCOSAL DISSECTION PROCEDURE WAS PERFORMED. DURING THE PROCEDURE, AFTER COAGULATION OF A SUBMUCOSAL VESSEL (SOFT COAGULATION, EFFECT 4, 80 W), A 6 MM SUPERFICIAL MUSCULAR LAYER THERMAL INJURY OCCURRED. DESPITE CARBON DIOXIDE INSUFFLATION, THE MUSCLE FIBERS DISSECTED AND THE INJURY WORSENED (FIG. 1A,B). THUS, A TROUGH-THE-SCOPE (TTS) CLIP WAS PLACED TO CLOSE THE DEFECT (FIG. 1C). IT WAS DECIDED TO COMPLETE THE RESECTION USING THE PIECEMEAL UNDERWATER ENDOSCOPIC MUCOSAL RESECTION (EMR) TECHNIQUE. COMPLETE RESECTION WAS ACHIEVED. AFTER EMR, DESPITE THE PREVIOUS PLACEMENT OF THE TTS CLIP, MUCOSAL DEFECT INSPECTION REVEALED EXPOSURE OF FAT UNDERNEATH THE MUSCULAR LAYER, SUGGESTIVE OF A TRANSMURAL DEFECT (FIG. 1D). THE CLIP WAS REMOVED WITH A FOREIGN BODY FORCEPS, CONFIRMING A 10 MM PERFORATION (FIG. 2A). A 14/6T OVER-THE-SCOPE CLIP (OTSC, OVESC

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Perforation

  MAUDE report 17941165 ↗
• InjurySep 12, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  OLYMPUS REVIEWED THE FOLLOWING LITERATURE TITLED "TREATMENT RESULTS AT OUR HOSPITAL AT THE TIME OF INTRODUCTION OF ENDOSCOPIC TREATMENT FOR SUPERFICIAL NON-PAPILLARY DUODENAL TUMORS." BACKGROUND: ENDOSCOPIC TREATMENT FOR SUPERFICIAL NON-PAPILLARY DUODENAL TUMORS (SNADET) REQUIRES HIGH TECHNICAL SKILLS DUE TO POOR OPERABILITY AND THIN MUSCLE LAYERS. IN ADDITION, IT IS IMPORTANT TO TAKE MEASURES AGAINST POST-BLEEDING AND DELAYED PERFORATION DUE TO PANCREATIC JUICE AND BILE EXPOSURE. METHODS: AT OUR HOSPITAL, WE STARTED SUBMUCOSAL DISSECTION (ESD) UNDER GENERAL ANESTHESIA FOR SNADET FROM (B)(6) 2022, AND ENDOSCOPIC MUCOSAL RESECTION UNDER IMMERSION (UEMR) UNDER SEDATION WITH MIDAZOLAM FROM (B)(6) OF THE SAME YEAR. UP TO (B)(6) 2023, SIX PATIENTS WITH ESD WERE IN GROUP E AND FIVE PATIENTS WHO UNDERWENT UEMR WERE IN GROUP U, AND THE TREATMENT OUTCOMES AT THE TIME OF ENDOSCOPIC TREATMENT INDUCTION OF SNADET WERE RETROSPECTIVELY EXAMINED. ONE PATIENT IN GROUP E UNDERWENT SEDATION WITH PROPOFOL BECAUSE THE LESION WAS LOCALIZED NEAR THE PYLORUS RING, AND ONE PATIENT IN GROUP U WAS EXCLUDED FROM PATHOLOGICAL ANALYSIS BECAUSE THE SPECIMEN COULD NOT BE RETRIEVED. ENDOSCOPIC PROCEDURE: ESD WAS

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 17730875 ↗
• MalfunctionAug 31, 2023Break; Break

  THE CUSTOMER REPORTED THAT THE TIP OF THE SUBJECT DEVICE WAS BROKEN. THE REPORTED ISSUE WAS OBSERVED DURING A THERAPEUTIC ESD (ENDOSCOPIC SUBMUCOSAL DISSECTION) PROCEDURE. THE INTENDED PROCEDURE WAS SUPPOSEDLY COMPLETED USING ANOTHER DEVICE. THERE WAS NO REPORT OF PATIENT OR USER INJURY DUE TO THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17661781 ↗