Olympus WA69416MRecalls & reported problems

Summary

The FDA's MAUDE database contains 12 adverse event reports that list this exact device (DI 04042761080002), received between Jan 26, 2022 and Mar 20, 2026 — classified as 1 injury, 11 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 16, 2026.

Most reported problems

Recent adverse event reports

The 12 most recent of 12 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 20, 2026Break

  IT WAS OBSERVED THAT DURING THE DEVICE EVALUATION, THE REUSABLE RIGID ENDOSCOPIC TISSUE MANIPULATION FORCEPS HAD A BROKEN DISTAL COMPONENT. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24654040 ↗
• MalfunctionJan 29, 2025Material Twisted/Bent; Material Twisted/Bent

  NO ADDITIONAL INFORMATION RECEIVED FROM THE CUSTOMER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21266077 ↗
• InjuryMar 8, 2024Break; Melted; Detachment of Device or Device Component; Break; Melted; Detachment of Device or Device Component

  IT WAS REPORTED, THAT THE PIN IN THE MOVABLE PART (FULCRUM PART) IS DAMAGED. AND SOME PARTS HAVE FALLEN OFF (SOME OF THE RECOVERED PIECES ARE PLACED IN A POUCH AND ATTACHED).

  Patient problems: Foreign Body In Patient

  MAUDE report 18864687 ↗
• MalfunctionJan 16, 2024Break; Break

  THE CUSTOMER REPORTED TO OLYMPUS THAT THE JAWS INSERT "HICURA", 5 X 330, MARYLAND, BIPOLAR HAD THE TIP SCORCHED DURING CLEANING WITH NO POWER BEING GENERATED ANYMORE THAN NECESSARY. THE ISSUE WAS FOUND DURING THE LAPAROSCOPIC UTERINE FIBROID ENUCLEATION PROCEDURE WHICH WAS COMPLETED WITH THE SAME DEVICE. THERE WERE NO REPORTS OF PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18521745 ↗
• MalfunctionNov 16, 2023Break; Sparking; Break; Sparking

  THE CUSTOMER REPORTED TO OLYMPUS, THE JAWS INSERT "HICURA", 5 X 330, MARYLAND, BIPOLAR HAD THE INSULATION AT THE TIP OF THE FORCEPS DAMAGED. THE ISSUE WAS FOUND DURING AN UNKNOWN THERAPEUTIC PROCEDURE. THERE WERE NO REPORTS OF PATIENT HARM. EVIDENCE OF SPARKING WAS FOUND DURING THE DEVICE EVALUATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18150407 ↗
• MalfunctionSep 5, 2023Mechanical Problem; Material Split, Cut or Torn; Mechanical Problem; Material Split, Cut or Torn

  THE CUSTOMER REPORTED TO OLYMPUS THAT THE JAWS INSERT "HICURA", 5 X 330, MARYLAND, BIPOLAR INNER PART TO MARYLAND BIPOLAR FORCEPS WAS BENT. THE EVENT WAS FOUND DURING REPROCESSING FOR A LAPAROSCOPIC HYSTERECTOMY. THERE WAS NO DELAY, AND THE PROCEDURE WAS COMPLETED WITH THE SAME DEVICE. THERE WAS NO PATIENT HARM ASSOCIATED WITH THE EVENT. THE DEVICE WAS EVALUATED, AND IT WAS FOUND THAT THE WHITE COMPONENT/PART ABOVE THE JAWS APPEARED TO BE BROKEN OR TORN AND THE JAWS WOULD NOT CLOSE COMPLETELY. THIS MDR (MEDICAL DEVICE REPORT) IS BEING SUBMITTED TO CAPTURE THE REPORTABLE MALFUNCTION FOUND DURING THE DEVICE EVALUATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17681839 ↗
• MalfunctionAug 8, 2023Break; Break

  THE CUSTOMER REPORTED THAT DURING AN UNSPECIFIED PROCEDURE THE TIP JAW WAS DAMAGED AND FELL OFF. THE PROCEDURE WAS COMPLETED WITH A SIMILAR DEVICE. THE TIP THAT FELL OFF HAS BEEN RECOVERED AND THERE IS NO HEALTH HAZARD. THERE WERE NO REPORTS OF PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17482420 ↗
• MalfunctionAug 8, 2023Break; Break

  AN OLYMPUS REPRESENTATIVE REPORTED ON BEHALF OF THE CUSTOMER SPARKS EMITTED FROM THE TIP OF JAWS INSERT "HICURA", 5 X 330, MARYLAND, BIPOLAR (OUTPUT 20W). THE MALFUNCTION WAS FOUND DURING THE THERAPEUTIC PROCEDURE, A SIMILAR DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO REPORTS OF PATIENT OR USER HARM ASSOCIATED WITH THIS EVENT. THE DEVICE WAS RETURNED, AND OLYMPUS REPAIR CENTER IDENTIFIED THE DISTAL END OF THE JAW WAS BROKEN. THIS MEDICAL DEVICE REPORT (MDR) IS BEING SUBMITTED TO CAPTURE THE REPORTABLE MALFUNCTIONS FOUND DURING THE EVALUATION OF THE RETURNED DEVICE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17481014 ↗
• MalfunctionJul 20, 2023Break; Mechanical Problem; Break; Mechanical Problem

  THE CUSTOMER REPORTED TO OLYMPUS, JAWS INSERT HICURA, 5 X 330, MARYLAND, BIPOLAR HAD BEEN IN CIRCULATION FOR ROUGHLY A MONTH. WHILE THE FORCEPS WAS BEING DECONTAMINATED, IT WAS NOTICED THAT A WHITE PIECE WAS MISSING OR BURNT AT THE BASE OF THE JAW OF THE INSERT. THE ISSUE WAS FOUND DURING REPROCESSING. THERE WERE NO REPORTS OF PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17358986 ↗
• MalfunctionMay 3, 2023Sparking; Sparking

  AN OLYMPUS REPRESENTATIVE REPORTED TO OLYMPUS ON BEHALF OF THE CUSTOMER THAT SPARKS FLEW FROM THE TIP OF THE JAWS INSERT "HICURA", 5 X 330, MARYLAND, BIPOLAR DURING A LAPAROSCOPIC HYSTERECTOMY. THE DEVICE WAS USED WITH A NON-OLYMPUS ELECTROSURGICAL UNIT WITH A 30 WATTS SETTING. THE USE OF THE DEVICE WAS DISCONTINUED. THE PROCEDURE WAS COMPLETED. THERE WAS NO HARM OR USER INJURY REPORTED DUE TO THE EVENT. UPON INSPECTION AND TESTING OF THE RETURNED DEVICE, IT WAS OBSERVED THAT THE INSULATION AND CERAMIC PIN WERE DAMAGED. THIS REPORT IS BEING SUBMITTED FOR THE EVENT FOUND DURING EVALUATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16865711 ↗
• MalfunctionFeb 9, 2023Sparking; Sparking

  DURING SURGERY (LAPAROSCOPIC HYSTERECTOMY), SPARKS WERE GENERATED FROM THE TIP. THERE WAS NO FALLING OFF OF FRAGMENTS, ETC., AND THERE WAS NO HEALTH HAZARD. IT WAS REPLACED WITH ANOTHER ONE AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16343393 ↗
• MalfunctionJan 26, 2022Break; Fracture; Material Fragmentation; Mechanical Problem; Break; Fracture; Material Fragmentation; Mechanical Problem

  OLYMPUS WAS INFORMED THAT DURING A THERAPEUTIC LAPAROSCOPIC HYSTERECTOMY PROCEDURE, THE SUREGON FELT THAT CAUTERIZING IN BIPOLAR BECAME DIFFICULT. THE DEPOSITS A THE DISTAL END OF THE JAWS INSERT WERE REMOVED WITH A GAUZE BUT CAUTERIZATION WAS STILL NOT POSSIBLE AND WHEN THE INSTRUMENT WAS REMOVED AGAIN TO BE REPLACED, A CRACK WAS NOTICED IN THE INSULATION AT THE DISTAL END OF THE JAWS. IT IS UNCLEAR WHETHER ANY FRAGMENTS MAY HAVE BROKEN OFF AND FALLEN INTO THE PATIENT. HOWEVER, THE INTENDED PROCEDURE WAS COMPLETED USING ANOTHER SIMILAR DEVICE AND THERE WAS NO REPORT ABOUT AN ADVERSE EVENT OR PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13357861 ↗