Olympus A6282Recalls & reported problems

Summary

The FDA's MAUDE database contains 29 adverse event reports that list this exact device (DI 04042761028868), received between Aug 21, 2018 and May 27, 2026 — classified as 2 injuries, 27 malfunctions.

The most frequently reported specific device problem is “Break” (14 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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 29 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 27, 2026Material Split, Cut or Torn

  DURING A LAPAROSCOPIC CHOLECYSTECTOMY, THE TIP OF THE HOOK ELECTRODE BROKE. NO HARM REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25303165 ↗
• MalfunctionMay 5, 2026Residue After Decontamination

  IT WAS REPORTED THAT THE ELECTRODE HAD WHITE FILM WAS ALL OVER THE HANDLE AFTER IT WAS CLEANED. THE ISSUE WAS FOUND AFTER REPROCESSING. NO HARM REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25083166 ↗
• MalfunctionApr 8, 2026Material Integrity Problem

  IT WAS REPORTED THAT THE INSULATION WAS DAMAGED. THERE WERE NO REPORTS OF ANY PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24818593 ↗
• MalfunctionMar 31, 2026Fracture; Electrical Shorting

  IT WAS REPORTED THE ENDOSCOPIC ELECTROSURGICAL ELECTRODE, MONOPOLAR, REUSABLE, EXHIBITED PART OF THE TUBE HAS BROKEN OFF, CAUSING AN ELECTRICAL SHORT. THERE WERE NO REPORTS OF PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24743916 ↗
• MalfunctionJan 20, 2026Degraded

  IT WAS REPORTED THAT THE SUBJECT DEVICE EXHIBITED INSULATION AT THE TIP IS DAMAGED. THERE WERE NO REPORTS OF PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24122127 ↗
• MalfunctionDec 19, 2025Break; Break

  IT WAS REPORTED THAT THE ENDOSCOPIC ELECTROSURGICAL ELECTRODE¿INSULATION HOOK SEPARATED. THE ISSUE WAS FOUND DURING INSPECTION FOR USE. THERE WERE NO REPORTS OF PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23858053 ↗
• MalfunctionNov 17, 2025Fracture; Fracture

  NO ADDITIONAL INFORMATION RECEIVED FROM THE CUSTOMER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23566573 ↗
• MalfunctionJun 13, 2025Crack; Crack

  IT WAS REPORTED THAT THE SUBJECT DEVICE EXHIBITED DAMAGED (CRACKED) INSULATION AT THE DISTAL END OF THE TUBE - DAMAGED HOOK. THERE WERE NO REPORTS OF PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22206373 ↗
• InjuryFeb 21, 2025Break; Detachment of Device or Device Component; Break; Detachment of Device or Device Component

  IT WAS REPORTED THAT THE INSULATION OF THE HOOK ELECTRODE BROKE OFF AND FELL INTO THE OPERATING FIELD DURING AN UNSPECIFIED PROCEDURE. THE SURGICAL TEAM RETRIEVED IT FROM THE OPERATING FIELD. THERE WERE NO REPORTS OF PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21437803 ↗
• InjuryJan 17, 2025Break; Detachment of Device or Device Component; Break; Detachment of Device or Device Component

  WHILE UNDER SEDATION FOR A LAPAROSCOPIC ENDOSCOPY THE TIP OF THE ELECTRODE BROKE OFF AND WAS UNABLE TO BE RETRIEVED. THIS LED TO A SURGICAL PROLONGATION GREATER THAN 30 MINUTES. THE PATIENT IS REPORTED STABLE AT THIS TIME.

  Patient problems: Foreign Body In Patient

  MAUDE report 21183801 ↗
• MalfunctionNov 27, 2024Material Discolored; Material Deformation; Material Discolored; Material Deformation

  NO ADDITIONAL INFORMATION RECEIVED FROM CUSTOMER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20790112 ↗
• MalfunctionDec 1, 2023Break; Break

  THE CUSTOMER REPORTED TO OLYMPUS THAT THE HF-ELECTRODE, HOOK, 5 X 330 MM HOOK AT THE DISTAL END OF THE TUBE WAS COMPLETELY BURNED AND A FRAGMENT OF THE DEVICE HAD BROKEN OFF. THE EVENT OCCURRED DURING REPROCESSING. THERE WAS NO PATIENT HARM ASSOCIATED WITH THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18245619 ↗
• MalfunctionOct 13, 2023Break; Break

  THE CUSTOMER REPORTED THAT THE INSULATION AT THE DISTAL END OF THE TUBE WAS BROKEN. THERE WERE NO REPORTS OF HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17935323 ↗
• MalfunctionAug 31, 2023Electrical /Electronic Property Problem; Electrical /Electronic Property Problem

  THE CUSTOMER REPORTED TO OLYMPUS, THAT DURING A THERAPEUTIC, LAPAROSCOPIC CHOLECYSTECTOMY PROCEDURE, THE ELECTRICITY WAS COMING BACK ONTO THE HF-ELECTRODE HOOK. THERE WERE NO REPORTS OF PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17667613 ↗
• MalfunctionAug 31, 2023Electrical /Electronic Property Problem; Electrical /Electronic Property Problem

  THE CUSTOMER REPORTED THAT WHEN USING AN HF-ELECTRODE, HOOK, 5 X 330 MM, THE ELECTRICITY WAS COMING BACK ONTO THE HOOK. THE EVENT OCCURRED DURING THE THERAPEUTIC PROCEDURE (LAPAROSCOPIC CHOLECYSTECTOMY). THE PROCEDURE WAS COMPLETED WITH THE SAME DEVICE. THERE WERE NO REPORTS OF HARM ASSOCIATED WITH THE EVENT. THIS REPORT IS LINKED TO PATIENT IDENTIFIERS:(B)(4). THIS REPORT BEING SUBMITTED IS FOR REPORT WITH PATIENT IDENTIFIER (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17666409 ↗
• MalfunctionAug 31, 2023Electrical /Electronic Property Problem; Electrical /Electronic Property Problem

  THE CUSTOMER REPORTED THAT WHEN USING AN HF-ELECTRODE, HOOK, 5 X 330 MM, THE ELECTRICITY WAS COMING BACK ONTO THE HOOK. THE EVENT OCCURRED DURING THE THERAPEUTIC PROCEDURE (LAPAROSCOPIC CHOLECYSTECTOMY). THE PROCEDURE WAS COMPLETED WITH THE SAME DEVICE. THERE WAS NO PATIENT HARM ASSOCIATED WITH THE EVENT. THIS REPORT IS LINKED TO PATIENT IDENTIFIERS: (B)(6).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17660956 ↗
• MalfunctionAug 14, 2023Break; Break

  THE CUSTOMER REPORTED THAT THE INSULATION OF THE HOOK WAS DAMAGED ON A HF-ELECTRODE, HOOK, 5 X 330 MM. THE EVENT OCCURRED DURING PREPARATION FOR USE. THE THERAPEUTIC PROCEDURE (LAPAROSCOPIC CHOLECYSTECTOMY) WAS COMPLETED WITH THE SAME DEVICE. THERE WAS NO PROCEDURAL DELAY, OR NO PATIENT HARM ASSOCIATED WITH THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17547029 ↗
• MalfunctionAug 14, 2023Break; Break

  THE CUSTOMER REPORTED THAT THE INSULATION OF THE HOOK WAS DAMAGED ON A HF-ELECTRODE, HOOK, 5 X 330 MM. THE EVENT OCCURRED DURING PREPARATION FOR USE. THE THERAPEUTIC PROCEDURE (LAPAROSCOPIC CHOLECYSTECTOMY) WAS COMPLETED WITH A SIMILAR DEVICE. THERE WAS NO PATIENT HARM ASSOCIATED WITH THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17546915 ↗
• MalfunctionJul 10, 2023Break; Break

  IT WAS REPORTED TO OLYMPUS THAT A HF-ELECTRODE HAD A BROKEN END. THE REPORTED ISSUE OCCURRED DURING REPROCESSING OF THE DEVICE. NO PROCEDURE WAS INVOLVED. THERE WAS NO PATIENT INJURY OR ADVERSE EVENT REPORTED TO OLYMPUS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17295328 ↗
• MalfunctionMay 30, 2023Detachment of Device or Device Component; Detachment of Device or Device Component

  THE CUSTOMER REPORTED TO OLYMPUS THAT THE HF-ELECTRODE, HOOK, 5 X 330 MM WHEN REMOVED THE A0358 FROM THE A6282 AFTER THE PRE¿SURGERY EQUIPMENT CHECKS, A SMALL PIECE OF METAL WAS FOUND DURING PREPARATION FOR USE. THE DAMAGE WAS FOUND BEFORE THE PROCEDURE AND THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17021903 ↗
• MalfunctionMay 5, 2023Crack; Crack

  IT WAS REPORTED TO OLYMPUS, THAT DURING MANUAL CLEANING OF A6282 USED IN SURGICAL LAPAROSCOPIC SURGERY. A PLASTIC PART IN FRONT OF THE ELECTRODE CHIPPED. THERE WAS NO PATIENT INJURY OR ADVERSE EVENT REPORTED TO OLYMPUS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16882246 ↗
• MalfunctionJun 13, 2022Break; Fracture; Material Fragmentation; Mechanical Problem; Break; Fracture; Material Fragmentation; Mechanical Problem

  OLYMPUS WAS INFORMED THAT DURING A THERAPEUTIC LAPAROSCOPIC MYOMECTOMY PROCEDURE THE CONNECTING PART OF THE ELECTRODE BROKE OFF AND FELL INTO THE PATIENT. THE SURGEON IMMEDIATELY REMOVED THE FRAGMENTS, HOWEVER, A 2MM FRAGMENT STILL SEEMED TO BE MISSING BUT COULD NOT BE LOCATED INSIDE THE PATIENT. THE PATIENT WAS DISCHARGED AFTER THE PROCEDURE WITHOUT ANY COMPLICATIONS AND THERE WAS NO REPORT ABOUT AN ADVERSE EVENT OR PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14673825 ↗
• MalfunctionMay 19, 2022Break; Fracture; Material Fragmentation; Mechanical Problem; Break; Fracture; Material Fragmentation; Mechanical Problem

  OLYMPUS WAS INFORMED THAT AFTER AN UNSPECIFIED PROCEDURE IT WAS NOTICED THAT A FRAGMENT OF ABOUT 1-2MM OF THE CERAMIC INSULATION AT THE DISTAL END OF THE HF HOOK ELECTRODE HAD BROKEN OFF DURING THE PROCEDURE AND FALLEN INTO THE PATIENT. SINCE THIS WAS ONLY NOTICED AFTER THE PROCEDURE, THE FRAGMENT MAY HAVE REMAINED INSIDE THE PATIENT. NO FURTHER INFORMATION WAS PROVIDED BUT THERE WAS NO REPORT ABOUT AND ADVERSE EVENT OR PATIENT INJURY.

  Patient problems: Foreign Body In Patient

  MAUDE report 14434513 ↗
• MalfunctionNov 24, 2021Break; Fracture; Material Fragmentation; Mechanical Problem; Break; Fracture; Material Fragmentation; Mechanical Problem

  OLYMPUS WAS INFORMED THAT AFTER A THERAPEUTIC LAPAROSCOPIC CHOLECYSTECTOMY PROCEDURE IT WAS NOTICED THAT THE HOOK AT THE DISTAL END OF THE HF RESECTION ELECTRODE WAS DEFORMED, BUT NO FRAGMENTS FELL INTO THE PATIENT. NO FURTHER INFORMATION WAS PROVIDED BUT THERE WAS NO REPORT ABOUT AN ADVERSE EVENT OR PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12868743 ↗
• MalfunctionMay 3, 2021Material Fragmentation; Material Fragmentation

  OLYMPUS WAS INFORMED THAT DURING A THERAPEUTIC LAPAROSCOPIC CHOLECYSTECTOMY PROCEDURE, THE COATING OF THE HANDLE CHIPPED AND FELL INTO THE PATIENT¿S BODY CAVITY. HOWEVER, NO FRAGMENTS REMAINED INSIDE THE PATIENT SINCE THEY WERE REPORTEDLY RETRIEVED AFTER AN INTRA-ABDOMINAL LAVAGE WAS PERFORMED. THE INTENDED PROCEDURE WAS SUCCESSFULLY COMPLETED WITH A SIMILAR DEVICE AND THERE WAS NO REPORT ABOUT AN ADVERSE EVENT OR PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11759110 ↗