Olympus WA69410MRecalls & reported problems

Summary

The FDA's MAUDE database contains 20 adverse event reports that list this exact device (DI 04042761079976), received between May 20, 2021 and Dec 22, 2025 — classified as 1 injury, 19 malfunctions.

The most frequently reported specific device problem is “Break” (10 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 20 most recent of 20 reports, in the reporter's own words as published by the FDA.

• MalfunctionDec 22, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT THE TIP WHERE IT ATTACHES TO THE HANDLE OF THE JAWS WAS LOOSE. NO HARM REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23863850 ↗
• MalfunctionSep 17, 2025Material Integrity Problem; Material Integrity Problem

  IT WAS REPORTED DURING MAINTENANCE, THE PROXIMAL INSULATION WAS DAMAGED ON SUBJECT DEVICE. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23075978 ↗
• MalfunctionSep 16, 2025Break; Break

  IT WAS REPORTED THAT THE¿SUBJECT DEVICE WHITE INSULATION IN THE JAWS WAS FLOSSED.¿THE ISSUE WAS FOUND DURING REPROCESSING. THERE WERE NO REPORTS OF PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23062015 ↗
• MalfunctionAug 27, 2025Break; Break

  IT WAS REPORTED THAT DURING REPROCESSING, THE JAWS INSERT BIPOLAR DEVICE WAS FOUND TO HAVE TEARING AT THE WHITE PIECE AT THE HEAD (DISTAL END) OF THE DEVICE. THERE WERE NO REPORTS OF PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22909254 ↗
• MalfunctionJul 30, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT THE METAL TIP WITH THE BALL DETACHED FROM THE FORCEPS. NO HARM REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22667652 ↗
• MalfunctionMay 28, 2025Defective Component; Defective Component

  IT WAS REPORTED THE SUBJECT DEVICE BECAME FLOSSED AFTER A VERY SHORT PERIOD OF TIME (DAMAGE TO THE JAW INSULATION ON THE BIPOLAR INSTRUMENT). THE ISSUE OCCURRED DURING REPROCESSING. THERE WERE NO REPORTS OF PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22096057 ↗
• MalfunctionApr 22, 2025Break; Break

  IT WAS REPORTED THAT FORCEPS HICURA MONOPOLAR HAD A DAMAGED TIP. THE ISSUE OCCURRED DURING UNKNOWN THERAPEUTIC PROCEDURE. THERE WERE NO REPORTS OF PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21886075 ↗
• MalfunctionJan 2, 2025Break; Detachment of Device or Device Component; Break; Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING A THERAPEUTIC GASTRO PROCEDURE USING THIS BIPOLAR HAND INSTRUMENT, A PART OF THE DEVICE JAW BROKE OFF AND WAS RETRIEVED. THE PROCEDURE WAS DELAYED LESS THAN 30 MINUTES. THE PROCEDURE WAS COMPLETED WITH A BACK UP DEVICE. THERE WAS NO REPORTED PATIENT HARM OR INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21057612 ↗
• MalfunctionOct 7, 2024Material Erosion; Material Erosion

  IT WAS OBSERVED DURING THE DEVICE INSPECTION, THAT THE BIPOLAR INSTRUMENT EXHIBITED THE INSULATING BODY LOCATED BETWEEN THE HALVES OF THE MOUTH WAS WORN. THERE WERE NO REPORTS OF PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20391268 ↗
• MalfunctionSep 13, 2023Material Split, Cut or Torn; Sharp Edges; Material Split, Cut or Torn; Sharp Edges

  THE CUSTOMER REPORTED TO OLYMPUS THAT, AFTER JUST STARTING TO USE THEIR HICURA BIPOLAR JAWS DEVICE IN AN UNKNOWN THERAPEUTIC PROCEDURE, IT WAS DISCOVERED THAT THERE WAS A NICK IN THE SIDE OF THE SHAFT. WHEN INITIALLY REPORTED IT WAS UNKNOWN IF THE ISSUE WAS NOTICED PRIOR TO OR DURING THE PROCEDURE PROPER, BUT THE CUSTOMER LATER CLARIFIED THAT THE ISSUE WAS FULLY CHARACTERIZED DURING A POST-OPERATIVE INSTRUMENT INSPECTION AFTER THE CASE WAS COMPLETED SUCCESSFULLY. UPON INSPECTION AND TESTING OF THE RETURNED UNIT ON (B)(6) 2023, IT WAS DISCOVERED THAT THE SHAFT AS WELL AS THE INSULATION OF THE DEVICE WAS DAMAGED HEAVILY WITH A LONG, DEEP SCRATCH, RESULTING IN METAL EXPOSURE. THERE WERE NO REPORTS OF PATIENT OR USER HARM ASSOCIATED WITH THIS EVENT. THIS MEDICAL DEVICE REPORT (MDR) IS BEING SUBMITTED TO CAPTURE THE REPORTABLE MALFUNCTION FOUND DURING EVALUATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17739274 ↗
• MalfunctionSep 6, 2023Unraveled Material; Unraveled Material

  THE CUSTOMER CONFIRMED THE DEVICE WAS CLEANED SEVENTY TIMES WITH DR. VEIGERT NEODISHER MEDICLEAN FORTE AND RINSED WITH DR. VEIGERT NEODISHER 2.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17690246 ↗
• MalfunctionSep 5, 2023Break; Mechanical Problem; Break; Mechanical Problem

  A USER FACILITY REPORTED TO OLYMPUS THE WHITE ISOLATION AT THE DISTAL TIP OF JAWS INSERT "HICURA", 5 X 330, JOHANN, BIPOLAR, TURNS FLUFFY AND MIGHT CAUSE DEBRIS. THE MALFUNCTION WAS FOUND DURING REPROCESSING. THERE WAS NO PATIENT HARM OR NO USER INJURY REPORTED DUE TO THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17682970 ↗
• MalfunctionSep 5, 2023Break; Mechanical Problem; Break; Mechanical Problem

  A USER FACILITY REPORTED TO OLYMPUS THE WHITE ISOLATION AT THE DISTAL TIP OF JAWS INSERT "HICURA", 5 X 330, JOHANN, BIPOLAR, TURNS FLUFFY AND MIGHT CAUSE DEBRIS. THE MALFUNCTION WAS FOUND DURING REPROCESSING. THERE WAS NO PATIENT HARM OR NO USER INJURY REPORTED DUE TO THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17682953 ↗
• MalfunctionSep 5, 2023Break; Mechanical Problem; Break; Mechanical Problem

  A USER FACILITY REPORTED TO OLYMPUS THE WHITE ISOLATION AT THE DISTAL TIP OF JAWS INSERT "HICURA", 5 X 330, JOHANN, BIPOLAR, TURNS FLUFFY AND MIGHT CAUSE DEBRIS. THE MALFUNCTION WAS FOUND DURING REPROCESSING. THERE WAS NO PATIENT HARM OR NO USER INJURY REPORTED DUE TO THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17682939 ↗
• InjuryAug 15, 2023Detachment of Device or Device Component; Detachment of Device or Device Component

  THE CUSTOMER REPORTED TO OLYMPUS THAT WHEN THIS HICURA HAND INSTRUMENT WAS INSERTED INTO THE ABDOMINAL CAVITY AND AN ATTEMPT WAS MADE TO GRIP THE TISSUE, THE JAW AT THE TIP FELL OFF. THE FALLEN PART HAS BEEN RECOVERED. THE PROCEDURE WAS COMPLETED USING ANOTHER FORCEPS. THE ISSUE OCCURRED AT THE FIRST USE AFTER BORROWING THE DEMO MACHINE. THE DEVICE WAS INSPECTED WITH NO ABNORMALITIES NOTED PRIOR TO USE. THERE WERE NO REPORTS OF FURTHER PATIENT OR USER HARM ASSOCIATED WITH THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17551974 ↗
• MalfunctionJul 14, 2023Material Frayed; Material Frayed

  THE CUSTOMER REPORTED TO OLYMPUS, THE WHITE INSULATION WAS COMING OFF THE DISTAL TIP OF THE JAWS, IN SMALL THREADS. THE ISSUE WAS FOUND DURING REPROCESSING. THERE WERE NO REPORTS OF PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17328104 ↗
• MalfunctionFeb 13, 2023Break; Break

  OLYMPUS (OJ) WAS INFORMED BY THE BIOMEDICAL ENGINEER AT THE USER FACILITY, DURING A LAPAROSCOPIC HYSTERECTOMY WHEN THE TISSUE WAS GRASPED WITH THE CUSTOMER HICURA, JOHANN BIPOLAR JAWS INSERT, THE TIP BROKE AND FELL OFF. AFTER REMOVING THE FALLEN PART OUTSIDE THE BODY, THE FORCEPS WAS REPLACED WITH A REPLACEMENT FORCEPS FROM ANOTHER COMPANY. THE PROCEDURE WAS COMPLETED. NO DEATH, INJURY OR IMPACT WAS REPORTED TO OLYMPUS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16364498 ↗
• MalfunctionDec 21, 2022Arcing; Arcing

  OLYMPUS WAS INFORMED THAT AFTER ONLY USE IN A LAPAROSCOPIC PROSTATECTOMY PROCEDURE THE JAWS INSERT BEGAN TO PRODUCE AN ELECTRIC ARC TO THE SOFT TISSUES IN THE AREA OF THE CERAMIC INSULATION. 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 16020466 ↗
• MalfunctionAug 16, 2021Break; Fracture; Material Fragmentation; Mechanical Problem; Break; Fracture; Material Fragmentation; Mechanical Problem

  OLYMPUS WAS INFORMED THAT DURING A THERAPEUTIC LAPAROSCOPIC OVARIAN TUMOR RESECTION PROCEDURE, WHEN THE BIPOLAR FORCEPS WERE REMOVED FROM THE PATIENT AND WIPED BY A NURSE, IT WAS NOTICED THAT THE WHITE INSULATION AT THE DISTAL END OF THE JAWS INSERT WAS BROKEN OFF AND MISSING. THE SURGEON ASSESSED IT AS UNLIKELY THAT A FRAGMENT MAY HAVE FALLEN INTO THE PATIENT BUT IT COULD NOT BE EXCLUDED COMPLETELY. HOWEVER, THE INTENDED PROCEDURE WAS COMPLETED USING THE SAME SET OF EQUIPMENT AND THERE WAS NO REPORT ABOUT AN ADVERSE EVENT OR PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12323916 ↗
• MalfunctionMay 20, 2021Break; Fracture; Material Fragmentation; Mechanical Problem; Break; Fracture; Material Fragmentation; Mechanical Problem

  OLYMPUS WAS INFORMED THAT DURING AN UNSPECIFIED THERAPEUTIC GYNECOLOGICAL PROCEDURE, THE DISTAL END OF THE JAWS INSERT BROKE AND A FRAGEMT FELL INTO THE PATIENT'S ABDOMINAL CAVITY. AN X RAY WAS PERFORMED BUT NO FRAGMENTS COULD BE LOCATED INSIDE THE PATIENT. THE INTENDED PROCEDURE WAS COMPLETED USING THE SAME SET OF EQUIPMENT AND THERE WAS NO REPORT ABOUT AN ADVERSE EVENT OR PATIENT INJURY.

  Patient problems: Foreign Body In Patient

  MAUDE report 11854203 ↗