Single Use Electrosurgical Hemostatic Forceps FD-410LRRecalls & reported problems

Summary

The FDA's MAUDE database contains 46 adverse event reports that list this exact device (DI 04953170208430), received between Feb 4, 2019 and Aug 13, 2025 — classified as 42 injuries, 4 malfunctions.

The most frequently reported specific device problem is “Failure to Deliver Energy” (4 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 46 reports, in the reporter's own words as published by the FDA.

• InjuryAug 13, 2025Failure to Seal; Failure to Seal

  IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE, THE SINGLE USE ELECTROSURGICAL HEMOSTATIC FORCEPS DID NOT PROVIDE HEMOSTASIS AND THE BLEEDING DID NOT STOP. ADDITIONAL INFORMATION WAS REQUESTED BUT NOT AVAILABLE AT THIS TIME. THERE WERE NO FURTHER REPORTS OF PATIENT HARM.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 22794016 ↗
• InjuryNov 27, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  OLYMPUS REVIEWED THE FOLLOWING LITERATURE TITLED "PERORAL ENDOSCOPIC MYOTOMY: SHORT VERSUS LONG ESOPHAGEAL MYOTOMY FOR ACHALASIA CARDIA: A RANDOMIZED CONTROLLED NONINFERIORITY TRIAL". LITERATURE SUMMARY BACKGROUND AND AIMS: THE APPROPRIATE LENGTH OF ESOPHAGEAL MYOTOMY IN PERORAL ENDOSCOPIC MYOTOMY (POEM) FOR ACHALASIA CARDIA REMAINS UNCLEAR. THIS STUDY AIMED TO COMPARE THE OUTCOME OF SHORT (= 3 CM) AND LONG (= 6 CM) ESOPHAGEAL MYOTOMY IN PATIENTS WITH TYPE I AND II ACHALASIA CARDIA. METHODS: THIS SINGLE-BLINDED, RANDOMIZED CONTROLLED NONINFERIORITY TRIAL WAS CONDUCTED AT A TERTIARY CENTER BETWEEN JULY 2021 AND DECEMBER 2021. PATIENTS WITH ACHALASIA TYPES I AND II WERE RANDOMIZED INTO SHORT (=3 CM) AND LONG (=6 CM) ESOPHAGEAL MYOTOMY GROUPS. THE PRIMARY OUTCOME OF THE STUDY WAS CLINICAL SUCCESS (ECKARDT SCORE =3) 1 YEAR AFTER THE PROCEDURE. THE SECONDARY OUTCOMES INCLUDED A COMPARISON OF TECHNICAL SUCCESS, OPERATING DURATION, OCCURRENCE OF INTRAOPERATIVE ADVERSE EVENTS, ALTERATIONS IN INTEGRATED RELAXATION PRESSURE (IRP), CHANGE IN BARIUM COLUMN HEIGHT AFTER 5 MINUTES (1 MO), AND GASTROESOPHAGEAL REFLUX DISEASE (3 MO) BETWEEN THE GROUPS. RESULTS: FIFTY-FOUR PATIENTS WERE RANDOMIZED

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Hemorrhage/Blood Loss/Bleeding

  MAUDE report 20791449 ↗
• InjuryNov 17, 2024No Device Output; No Device Output

  IT WAS REPORTED THAT THE HEMOSTATIC FORCEPS DID NOT WORK IN THE MIDDLE OF A THERAPEUTIC PROCEDURE. THE INTENDED PROCEDURE WAS A HEMOSTASIS UNDERTAKEN DUE TO LESION IN THE WALL OF THE UPPER DIGESTIVE TRACT. THE HEMOSTATIC FORCEPS DID NOT WORK IN THE MIDDLE OF THE PROCEDURE. THE PATIENT EXPERIENCED LOSS OF FLUIDS/BLEEDING AND ANESTHESIA TIME WAS GREATLY EXTENDED. THE PATIENT WAS REPORTED TO HAVE A CARDIAC ISSUE WITH A CARDIAC RHYTHM REGULATING DEVICE (TO REGULATE THE HEART RATE). ALSO, THE LESION WAS SUBJECTED TO DIFFERENT TYPE OF DEVICES TO ENSURE ADEQUATE RESULT. AS SUCH, OTHER NONINVASIVE HEMOSTASIS METHODS WERE USED DUE TO PATIENT'S CONDITION IN CONSULTATION WITH CARDIOLOGY TO COMPLETE THE PROCEDURE SAFELY AT A LATER DATE. REPORTEDLY THE BLEEDING WAS ABLE TO BE CONTROLLED, AND THE INTENDED PROCEDURE WAS CANCELLED AND "RESUMED" AFTER A FEW DAYS. THE PATIENT'S CONDITION IS REPORTED AS "CONTROLLED".

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 20702260 ↗
• InjuryNov 13, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  OLYMPUS REVIEWED THE FOLLOWING LITERATURE TITLED "SAFETY OF EDOXABAN FOR DELAYED BLEEDING IN GASTROINTESTINAL ENDOSCOPIC PROCEDURES WITH A HIGH RISK OF BLEEDING." THIS STUDY INVESTIGATED THE SAFETY OF GASTROINTESTINAL ENDOSCOPIC PROCEDURES IN PATIENTS TAKING EDOXABAN, A DIRECT ORAL ANTICOAGULANT, FOCUSING ON THE INCIDENCE OF DELAYED BLEEDING DURING THE PERIOPERATIVE PERIOD. CONDUCTED FROM JUNE 2018 TO SEPTEMBER 2021, THE SINGLE-CENTER, OPEN-LABEL STUDY INCLUDED 21 PATIENTS ON EDOXABAN UNDERGOING HIGH-RISK ENDOSCOPY. THE PRIMARY OUTCOME, SEVERE DELAYED BLEEDING (CTCAE GRADES III¿V), OCCURRED IN 14% OF PATIENTS, ALL REQUIRING ENDOSCOPIC HEMOSTASIS. NO CASES OF MILD OR MODERATE DELAYED BLEEDING (CTCAE GRADES I-II) OR THROMBOEMBOLIC EVENTS WERE OBSERVED. SECONDARY OUTCOMES INCLUDED COMPLICATIONS LIKE CHOLANGITIS AND ASPIRATION PNEUMONIA, WHICH WERE CONSERVATIVELY TREATED, AND THE MEDIAN HOSPITAL STAY WAS 8 DAYS. PATIENTS WITH DELAYED BLEEDING HAD HIGHER SYSTOLIC BLOOD PRESSURE AT ADMISSION AND LONGER HOSPITAL STAYS. THE STUDY FOUND THAT THE INCIDENCE OF DELAYED BLEEDING IN THESE PATIENTS WAS ACCEPTABLE, WITH HIGHER SYSTOLIC BLOOD PRESSURE AT ADMISSION ASSOCIATED WITH INCREASED RISK, AL

  Patient problems: Aspiration Pneumonitis; Cholangitis; Hemorrhage/Blood Loss/Bleeding

  MAUDE report 20678096 ↗
• InjuryOct 18, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  OLYMPUS REVIEWED A LITERATURE TITLED "REBLEEDING RISK OF ACUTE HEMORRHAGIC RECTAL ULCER: A MULTICENTER RETROSPECTIVE STUDY". ACUTE HEMORRHAGIC RECTAL ULCER (AHRU) IS CHARACTERIZED BY SUDDEN, PAINLESS, AND MASSIVE BLEEDING FROM RECTAL ULCERS. TO DATE, FEW STUDIES HAVE ANALYZED THE RISK FACTORS FOR AHRU REBLEEDING. IN THIS STUDY, WE CLARIFIED THE RISK FACTORS OF REBLEEDING AFTER INITIAL HEMOSTASIS OF AHRU THROUGH A MULTICENTER STUDY. TYPE OF ADVERSE EVENTS/NUMBER OF PATIENTS. THE FOLLOWING EVENTS HAVE BEEN REPORTED IN THE LITERATURE. REBLEEDING (35 CASES). REBLEEDING WAS OBSERVED IN 35 PATIENTS (23%), AND THE MEAN TIME FROM INITIAL BLEEDING TO REBLEEDING WAS 5.2 DAYS. THE MEAN NUMBER OF EPISODES WAS 1.8 TIMES. THE MAXIMUM NUMBER OF REBLEEDING EPISODES EXPERIENCED BY A PATIENT WAS SEVEN. ONE PATIENT WITH REFRACTORY BLEEDING, IN WHOM HEMOSTASIS WAS UNSUCCESSFUL, UNDERWENT EMBOLIZATION. MULTIPLE HEMOSTATIC PROCEDURES WERE PERFORMED ONCE IN 3 PATIENTS (3.6%) USING A COMBINATION OF CLIPS AND HEMOSTATIC FORCEPS.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 20484626 ↗
• InjurySep 23, 2024Failure to Seal; Failure to Seal

  IT WAS REPORTED THAT DURING A ENDOSCOPIC SUBMUCOSAL DISSECTION (ESD) PROCEDURE, THE ELECTROSURGICAL GENERATOR WAS USED IN COMBINATION WITH ELECTROSURGICAL HEMOSTATIC FORCEPS AND THE ELECTRICAL OUTPUT WAS WEAK AND SO HEMOSTASIS COULD NOT BE ACHIEVED. THE FORCEPS WAS REPLACED BY ANOTHER ONE BUT NO IMPROVEMENT IN THE ABILITY TO ACHIEVE HEMOSTASIS. THE PROCEDURE WAS COMPLETED WITH ANOTHER DEVICE WITH A DELAY OF 10-15 MINUTES. FOLLOW-UP IDENTIFIED THAT SALINE WAS SPRAYED TO CLEAR BLEEDING SITE AND DRAIN THE BLOOD AS THE PATIENT WAS BLEEDING A LOT. THE SETTING VALUE OF THE DEVICE WAS NORMAL (¿SAME AS USUAL¿) BUT THE BLEEDING COULD NOT BE STOPPED. AFTER REPLACING WITH ANOTHER FORCEPS, A CABLE CORD FROM ANOTHER MANUFACTURER (A TROUBLESHOOTING MEASURE) AND OTHER SIMILAR DEVICE, THE PROCEDURE WAS ABLE TO BE COMPLETED. THE DEVICE WAS INSPECTED, AND NO ABNORMALITIES WERE FOUND. ALSO, IT WAS REPORTED THAT THERE WAS NO ISSUE WITH THE FORCEPS USED.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 20280934 ↗
• 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 20272976 ↗
• InjuryAug 12, 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: Hematemesis; Hemorrhage/Blood Loss/Bleeding; Melena; Unspecified Blood or Lymphatic problem

  MAUDE report 19968900 ↗
• 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." 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 19455683 ↗
• InjuryJun 3, 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: Fistula; Hemorrhage/Blood Loss/Bleeding; Pneumoperitoneum; Pneumothorax

  MAUDE report 19455614 ↗
• InjuryApr 23, 2024Failure to Deliver Energy; Failure to Deliver Energy

  IT WAS REPORTED DURING THE SURGERY, THE SUBJECT DEVICE HAD NO OUTPUT UPON PINCHING THE TISSUE. THE BLEEDING WAS STOPPED WITH A CLIP AND THE PROCEDURE WAS COMPLETED WITH NO HEALTH AFFECT TO THE PATIENT'S HEALTH.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 19168590 ↗
• InjuryFeb 27, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT DURING A THERAPEUTIC ENDOSCOPIC SUBMUCOSAL DISSECTION A PERFORATION OCCURRED IN THE STOMACH. THE HOLE WAS CLOSED WITH A PAPER CLIP AND THE PROCEDURE WAS CANCELLED. THE PATIENT IS UNDER OBSERVATION. THE DOCTOR DID NOT SAY IT WAS A DEVICE MALFUNCTION. THE PATIENT WAS HOSPITALIZED AND IS UNDER OBSERVATION.

  Patient problems: Internal Organ Perforation

  MAUDE report 18793850 ↗
• 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 (B)(6) HOSPITAL BETWEEN (B)(6) 2006 AND (B)(6) 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 CONTROLLED USING HE

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

  MAUDE report 18750730 ↗
• InjuryJan 15, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  OLYMPUS REVIEWED THE LITERATURE TITLED: "INDICATIONS FOR DENTAL FLOSS CLIP TRACTION DURING GASTRIC ENDOSCOPIC SUBMUCOSAL DISSECTION BY LESS-EXPERIENCED ENDOSCOPISTS." THIS RETROSPECTIVE STUDY INVESTIGATED THE INDICATIONS OF DENTAL FLOSS CLIP (DFC) IN ENDOSCOPIC SUBMUCOSAL DISSECTION (ESD) PERFORMED BY LESS-EXPERIENCED ENDOSCOPISTS FOR EARLY GASTRIC CANCER. A TOTAL OF 812 PATIENTS WERE INCLUDED. THE PROCEDURE TIME IN THE DFC (+) GROUP WAS SIGNIFICANTLY SHORTER THAN THAT IN THE DFC (-) GROUP (95±46 VS. 75±31, P<0.01). THE PROCEDURE TIME FOR LESIONS LOCATED IN THE GREATER CURVATURE OF THE UPPER OR MIDDLE STOMACH AND LESIONS >20 MM LOCATED IN THE LESSER CURVATURE SIDE OF THE STOMACH IN THE DFC (+) GROUP WAS SIGNIFICANTLY SHORTER THAN THAT IN THE DFC (-) GROUP. TYPE OF ADVERSE EVENTS/NUMBER OF PATIENTS: DELAYED BLEEDING - 30 PATIENTS, PERFORATION - 10 PATIENTS. DELAYED BLEEDING WAS DEFINED AS CLINICAL BLEEDING AFTER ESD THAT REQUIRED BLOOD TRANSFUSION OR ENDOSCOPIC OR SURGICAL INTERVENTION. PERFORATION WAS DIAGNOSED WHEN MESENTERIC FAT OR INTRA-ABDOMINAL SPACE WAS OBSERVED DURING THE PROCEDURE OR WHEN FREE AIR WAS IDENTIFIED ON SIMPLE CHEST AND ABDOMINAL RADIOGRAPHS AFTER ESD. RELATED P

  Patient problems: Hemorrhage/Blood Loss/Bleeding; Perforation

  MAUDE report 18515222 ↗
• InjuryAug 3, 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 "TECHNICAL OUTCOMES AND POSTPROCEDURAL COURSES OF MUCOSAL INCISION-ASSISTED BIOPSY FOR POSSIBLE GASTRIC GASTROINTESTINAL STROMAL TUMORS:A SERIES OF 48 CASES(WITH VIDEO)." MUCOSAL INCISION-ASSISTED BIOPSY (MIAB) HAS BEEN INTRODUCED AS AN ALTERNATIVE TO ENDOSCOPIC ULTRASOUND-GUIDED FINE NEEDLE ASPIRATION FOR TISSUE SAMPLING OF SUBEPITHELIAL LESIONS. HOWEVER, THERE HAVE BEEN FEW REPORTS ON MIAB, AND THE EVIDENCE IS LACKING, PARTICULARLY IN SMALL LESIONS. IN THIS CASE SERIES, WE INVESTIGATED THE TECHNICAL OUTCOMES AND POSTPROCEDURAL INFLUENCES OF MIAB FOR GASTRIC SUBEPITHELIAL LESIONS 10 MM OR GREATER IN SIZE. TYPE OF ADVERSE EVENTS/NUMBER OF PATIENTS - POSTOPERATIVE BLEEDING (N=1). NO INTRAOPERATIVE ADVERSE EVENTS OCCURRED, WHEREAS ONE PATIENT WITH SUBEPITHELIAL LESION GREATER THAN 20MM EXPERIENCED HAEMATEMESIS THE DAY AFTER MIAB. IN THIS CASE, NO BLEEDING WAS FOUND ON EMERGENCY ENDOSCOPY, AND THE PATIENT HAD NO SYMPTOMS THEREAFTER WITHOUT TRANSFUSION OR HEMOSTATIC TREATMENT. THIS EVENT REQUIRES 4 REPORTS. THE PATIENT IDENTIFIERS ARE AS FOLLOWS: (B)(6) : GIF-Q260J, (B)(6) : D-201-11804, (B)(6) :FD-410LR, (B)(6) : HX-610

  Patient problems: Hematemesis; Hemorrhage/Blood Loss/Bleeding

  MAUDE report 17450097 ↗
• InjuryJun 21, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  OLYMPUS REVIEWED THE FOLLOWING LITERATURE TITLED "ENDOSCOPIC SUBMUCOSAL DISSECTION FOR ANASTOMOTIC LESIONS AFTER COLORECTAL SURGERY." ABSTRACT: BACKGROUND: ENDOSCOPIC SUBMUCOSAL DISSECTION (ESD) FOR ANASTOMOTIC LESIONS IS TECHNICALLY CHALLENGING. WE AIMED TO CHARACTERIZE THE CLINICOPATHOLOGIC CHARACTERISTICS, FEASIBILITY, AND EFFECTIVENESS OF ESD FOR ANASTOMOTIC LESIONS OF THE LOWER GASTROINTESTINAL TRACT. METHOD: WE RETROSPECTIVELY INVESTIGATED 55 PATIENTS WITH ANASTOMOTIC LESIONS OF THE LOWER GASTROINTESTINAL TRACT WHO UNDERWENT ESD FROM FEBRUARY 2008 TO JANUARY 2021. THE LESIONS INVOLVING ONE OR BOTH SIDES OF ANASTOMOSES WERE CLASSIFIED INTO THE UNILATERALLY INVOLVING ANASTOMOSIS (UIA) OR STRADDLING ANASTOMOSIS (SA) GROUP, RESPECTIVELY. WE COLLECTED CLINICOPATHOLOGICAL CHARACTERISTICS, PROCEDURE-RELATED PARAMETERS AND OUTCOMES, AND FOLLOW-UP DATA AND ANALYZED THE IMPACT OF ANASTOMOTIC INVOLVEMENT. RESULTS: THE MEAN AGE WAS 62.5 YEARS, AND THE MEDIAN PROCEDURE DURATION WAS 30 MIN. THE RATES OF EN BLOC RESECTION AND R0 RESECTION WERE 90.9% AND 85.5%, RESPECTIVELY. FOUR PATIENTS (7.3%) EXPERIENCED MAJOR ADVERSE EVENTS (AES). DURING A MEDIAN FOLLOW-UP OF 66 MONTHS (RANGE 14¿169), SE

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

  MAUDE report 17176042 ↗
• InjuryJun 20, 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, "HIGH PROFICIENCY OF ESOPHAGEAL ENDOSCOPIC SUBMUCOSAL DISSECTION (ESD) WITH A "TUNNEL + CLIP TRACTION" STRATEGY: A LARGE FRENCH MULTICENTRIC STUDY." LITERATURE SUMMARY THIS STUDY AIMED TO ASSESS THE TECHNICAL RESULTS AND OUTCOMES OF A "TUNNEL+CLIP" STRATEGY FOR ESOPHAGEAL ESD PROCEDURES PERFORMED BY LESS EXPERIENCED OPERATORS FOR THE TREATMENT OF SUPERFICIAL NEOPLASMS. A TOTAL 195 ESOPHAGEAL ESD PROCEDURES PERFORMED. THE PERCENTAGE OF RESECTED ESOPHAGEAL CIRCUMFERENCE IN SUPERFICIAL SQUAMOUS CELL CARCINOMAS (SSC) TENDED TO BE HIGHER THAN THAT IN HIGH-GRADE DYSPLASIA (HGD)/ADENOCARCINOMA (ADK) COMPLICATING BARRETT¿S ESOPHAGUS (BE). THE EN BLOC, R0 AND CURATIVE RESECTION RATES WERE BOTH HIGHER IN HGD/ADK COMPLICATING BE THAN IN SSCS. NO SIGNIFICANT DIFFERENCE WAS FOUND IN TERMS OF R0 RESECTION, RATE OF PERFORMING THE PROCEDURE, OR PERFORATION ACCORDING TO THE LOCATION OF THE LESION (UPPER THIRD, MIDDLE THIRD, LOWER THIRD, ESOPHAGOGASTRIC JUNCTION). THE ¿TUNNEL+CLIP¿ STRATEGY IS SAFE, AND ALLOWS TO ACHIEVE HIGH EN BLOC, R0 AND CURATIVE RESECTION RATES. TYPE OF ADVERSE EVENTS/NUMBER OF PATIENTS EVENT1: PERFORATION - 1 P

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

  MAUDE report 17168101 ↗
• InjuryJun 7, 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, "TREATMENT WITH VONOPRAZAN FOR 3 WEEKS IS NOT INFERIOR TO 8 WEEKS FOR THE MANAGEMENT OF GASTRIC ENDOSCOPIC SUBMUCOSAL DISSECTION (ESD):A MULTICENTER NONINFERIORITY RANDOMIZED STUDY." ABSTRACT VONOPRAZAN, A POTASSIUM-COMPETITIVE ACID BLOCKER (VPZ), SIGNIFICANTLY REDUCES POSTOPERATIVE BLEEDING AFTER GASTRIC ESD; HOWEVER, THERE IS NO CONSENSUS ON THE APPROPRIATE TREATMENT DURATION. WE CONDUCTED A RANDOMIZED CONTROLLED STUDY TO DEMONSTRATE THAT THE 3-WEEK ADMINISTRATION OF VPZ IS NOT INFERIOR TO THE 8-WEEK ADMINISTRATION FOR ULCER HEALING. TYPE OF ADVERSE EVENTS/NUMBER OF PATIENTS BLEEDING N=7. PATIENT IDENTIFIERS: (B)(6) :KD-655L. (B)(6) :KD-611L. (B)(6) :FD-410LR. (B)(6) :WB991046 (ESG-100). THIS REPORT IS FOR (B)(6).

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 17078892 ↗
• InjuryMay 16, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE AUTHOR CONFIRMS THERE WERE NO OLYMPUS DEVICE MALFUNCTION AND NO OLYMPUS DEVICE CAUSED OR CONTRIBUTED TO ANY OF THE PATIENT ADVERSE EVENT.

  Patient problems: Hemorrhage/Blood Loss/Bleeding; Perforation; Unspecified Tissue Injury

  MAUDE report 16938068 ↗
• 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 16918046 ↗
• InjuryMay 9, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  OLYMPUS REVIEWED THE FOLLOWING LITERATURE TITLED "EVALUATION OF ANTIREFLUX MUCOSECTOMY FOR SEVERE GASTROESOPHAGEAL REFLUX DISEASE: MEDIUM-TERM RESULTS OF A PILOT STUDY". THE AIM OF OUR STUDY WAS TO EVALUATE THE MEDIUM-TERM EFFICACY OF THE ANTIREFLUX MUCOSECTOMY (ARMS) TECHNIQUE FOR PATIENTS WITH SEVERE GASTROESOPHAGEAL REFLUX DISEASE (GERD) SYMPTOMS (PROTON PUMP INHIBITORS (PPI)-TREATMENT-DEPENDENT OR PPI TREATMENT-RESISTANT GERD). A TOTAL OF 13 PATIENTS WERE INCLUDED. AFTER 24 MONTHS ARMS, GERD SYMPTOMS WERE SIGNIFICANTLY IMPROVED FOR THE 11 REMAINING PATIENTS, FOR WHOM MEDIAN GERD-HRQL SCORE DECREASED FROM 33 (IQR 26-42) TO 3 (IQR 0-7) (P = 0:001). HEARTBURN, REGURGITATION AND DYSPHAGIA HAD DISAPPEARED FOR ALL THE PATIENTS AT 24 MONTHS. DESPITE THESE SHORT-TERM ADVERSE EVENTS, THE OVERALL PATIENT SATISFACTION IN REDUCING GERD SYMPTOMS WAS VERY GOOD, 9/11 PATIENTS (81%) WERE WILLING TO REPEAT ARMS IF NEEDED. IN THIS PILOT STUDY, ARMS OF ESOPHAGOGASTRIC JUNCTION (EGJ) WAS A FEASIBLE AND EFFECTIVE MEDIUM-TERM TECHNIQUE FOR GERD TREATMENT WITH A RELATIVELY HIGH MORBIDITY RATE. TYPE OF ADVERSE EVENTS/NUMBER OF PATIENTS: INTRAOPERATIVE BLEEDING - 13 PATIENTS. *13 PATIENTS HAD INTRAOPER

  Patient problems: Hemorrhage/Blood Loss/Bleeding; Melena; Pain

  MAUDE report 16895068 ↗
• InjuryMay 8, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  OLYMPUS FURTHER RECEIVED INFORMATION FROM THE AUTHOR/PHYSICIAN THAT THE EVENTS DESCRIBE IN THE STUDY ARE CONSIDERED NORMAL FOR THE TECHNIQUE USED. FURTHERMORE, THE PHYSICIAN CONFIRMED THAT NO OLYMPUS DEVICE CONTRIBUTE TO THE EVENTS DESCRIBED IN THE STUDY.

  Patient problems: Hemorrhage/Blood Loss/Bleeding; Perforation

  MAUDE report 16892609 ↗
• InjuryApr 12, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  OLYMPUS REVIEWED THE FOLLOWING LITERATURE TITLED "ENDOSCOPIC SUBMUCOSAL DISSECTION FOR LARGE DUODENAL LATERALLY SPREADING LESIONS IS FEASIBLE: A MULTI-CENTER RETROSPECTIVE STUDY". THIS MULTICENTRIC RETROSPECTIVE STUDY SOUGHT TO ASSESS THE EFFECT AND SAFETY OF ESD FOR LARGE LATERALLY SPREADING LESIONS LOCATED IN THE DESCENDING DUODENUM BASED ON MULTI-CENTER EXPERIENCES. A TOTAL OF 51 PATIENTS WERE INCLUDED. THE AVERAGE PROCEDURE TIME FOR EN BLOC RESECTION RANGING FROM 20 TO 117 MIN (MEDIAN: 45.5 MIN). TWO PATIENTS EXPERIENCED DELAYED BLEEDING 3 DAYS AFTER ESD AND 2 OTHER PATIENTS WERE DIAGNOSED WITH DELAYED PERFORATION. ALL THE PATIENTS WERE CLOSELY FOLLOWED UP FOR A MEDIAN PERIOD OF 16 MONTHS (RANGE 7 TO 29 MONTHS), AND THERE WERE NO DEATHS. NO RESIDUAL TUMOR AND LOCAL RECURRENCE OCCURRED DURING FOLLOW-UP. ESD FOR LATERALLY SPREADING LESIONS OF THE DESCENDING DUODENUM IS A FEASIBLE THERAPEUTIC PROCEDURE AND CAN ACHIEVE A FAVORABLE EN BLOC RESECTION RATE. TYPE OF ADVERSE EVENTS/NUMBER OF PATIENTS: DELAYED BLEEDING: CASE 1. DELAYED BLEEDING: CASE 2. DELAYED PERFORATION (POSTOPERATIVE FEVER, MILD ABDOMINAL PAIN): CASE 3. DELAYED PERFORATION (FEVER, SEVERE ABDOMINAL PAIN, DIFFUSE PERIT

  Patient problems: Abdominal Pain; Fever; Perforation; Peritonitis

  MAUDE report 16728378 ↗
• 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

  MAUDE report 16726493 ↗
• 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 16723854 ↗