Olympus WA69334MRecalls & reported problems

Summary

The FDA's MAUDE database contains 15 adverse event reports that list this exact device (DI 04042761079426), received between Sep 18, 2023 and Mar 10, 2026 — classified as 4 injuries, 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 15 most recent of 15 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 10, 2026Break; Detachment of Device or Device Component

  IT WAS REPORTED THAT THE RIGID ENDOSCOPIC TISSUE MANIPULATION FORCEPS, REUSABLE DEVICE HAD A BROKEN DISTAL END. THE ISSUE WAS OBSERVED DURING SET UP / INSPECTION FOR USE (DURING SET UP IN ROOM / BEFORE PATIENT IN ROOM). THERE WERE NO REPORTS OF PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24560641 ↗
• MalfunctionDec 12, 2025Break; Break

  IT WAS REPORTED THAT DURING SET UP FOR AN UNKNOWN PROCEDURE, THE TIP BROKE OFF THE INSERT ON ASSEMBLY. THE TIP WAS LOOSE AND HAD TO BE PINCHED TOGETHER TO GET IT INTO THE SHAFT. THERE WAS NO REPORTED PATIENT HARM OR INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23790108 ↗
• InjuryDec 12, 2025Break; Detachment of Device or Device Component; Break; Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE THE TIP BROKEN OFF IN THE PATIENT'S ABDOMEN. THERE WAS NO REPORTED INJURY OR HARM TO THE PATIENT. FOLLOW UP WITH THE CUSTOMER FOR MORE INFORMATION IS PENDING.

  Patient problems: Foreign Body In Patient

  MAUDE report 23789961 ↗
• MalfunctionDec 12, 2025Break; Break

  NO ADDITIONAL INFORMATION WAS RECEIVED FROM THE CUSTOMER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23789953 ↗
• MalfunctionJul 14, 2025Mechanics Altered; Mechanics Altered

  IT WAS REPORTED THE WORKING TIPS OF THE JAWS EASILY BECAME MISALIGNED RENDERING THE INSERT USELESS. THE ISSUE OCCURRED DURING REPROCESSING. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22495728 ↗
• InjuryJun 26, 2025Break; Break

  IT WAS REPORTED DURING SEDATION FOR AN UNKNOWN THERAPEUTIC LAPAROSCOPIC PROCEDURE PART OF THE DEVICE BROKE OFF INTO THE ABDOMINAL AREA. THE PART WAS RETRIEVED AND THE PROCEDURE WAS COMPLETED USING A BACK UP DEVICE. NO REPORTS OF PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22338429 ↗
• InjuryJun 26, 2025Break; Break

  IT WAS REPORTED DURING SEDATION FOR AN UNKNOWN THERAPEUTIC LAPAROSCOPIC PROCEDURE PART OF THE DEVICE BROKE OFF INTO THE ABDOMINAL AREA. THE PART WAS RETRIEVED AND THE PROCEDURE WAS COMPLETED USING A BACK UP DEVICE. NO REPORTS OF PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22338338 ↗
• InjuryJun 26, 2025Break; Detachment of Device or Device Component; Break; Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING A THERAPEUTIC LAPAROSCOPIC APPENDECTOMY PROCEDURE, THE WAVY GRASPER TIP BROKE OFF IN THE PERITONEAL SPACE OF THE PATIENT. IT WAS NOT NOTICED IMMEDIATELY. THE SCRUB NURSE LATER NOTICED THAT THE TIP WAS MISSING FROM THE INSTRUMENT. THE SURGEON WENT INTO THE PERITONEAL SPACE WITH ANOTHER INSTRUMENT, LOCATED THE WAVY GRASPER TIP AND REMOVED IT FROM THE PATIENT. THE PROCEDURE WAS COMPLETED USING A BACKUP DEVICE. THERE WERE NO FURTHER REPORTS OF PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22334269 ↗
• MalfunctionAug 26, 2024Failure to Align; Failure to Align

  IT WAS REPORTED THE RIGID ENDOSCOPIC TISSUE MANIPULATION FORCEPS JAWS WERE MISALIGNED. THE ISSUE OCCURRED DURING REPROCESSING. THERE WERE NO REPORTS OF PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20069291 ↗
• MalfunctionAug 22, 2024Failure to Align; Failure to Align

  IT WAS REPORTED THAT THE RIGID ENDOSCOPIC TISSUE MANIPULATION FORCEPS JAWS WERE MISALIGNED. THERE WERE NO REPORTS OF PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20028893 ↗
• MalfunctionAug 19, 2024Break; Break

  IT WAS REPORTED THAT THE RIGID ENDOSCOPIC TISSUE MANIPULATION FORCEPS DISTAL END OF THE JAW WAS BROKEN OR DEFORMED. THERE WERE NO REPORTS OF PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19999880 ↗
• MalfunctionOct 20, 2023Failure to Align; Failure to Align

  THE CUSTOMER REPORTED WHEN USING THE DEVICE FOR THE FIRST TIME DURING A LAPAROSCOPIC LIVER RESECTION, IT WAS NOTICED THERE WAS SOME DISCOMFORT IN ITS OPERABILITY FROM THE BEGINNING, SO IT WAS CHECKED. THE CUSTOMER NOTICED THAT THE TIP OF THE JAWS WAS SLIGHTLY MISALIGNED. THE PROCEDURE WAS COMPLETED WITH THE SAME SET OF EQUIPMENT. NO HEALTH DAMAGE TO PATIENTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17979939 ↗
• MalfunctionSep 29, 2023Material Deformation; Material Deformation

  IT WAS REPORTED THAT THE GRASPING FORCEPS HAD MISALIGNED JAWS AND COULD NOT BE USED. THE ISSUE WAS FOUND OUT OF THE BOX. NO PATIENT OR PROCEDURE WAS INVOLVED. THERE WERE NO REPORTS OF HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17848389 ↗
• MalfunctionSep 25, 2023Material Deformation; Material Deformation

  THE CUSTOMER REPORTED THAT THE GRASPING FORCEPS HAD MISALIGNED JAWS AND COULD NOT BE USED. THERE WERE NO REPORTS OF HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17814079 ↗
• MalfunctionSep 18, 2023Failure to Align; Failure to Align

  THE CUSTOMER REPORTED THAT HER OLYMPUS HICURA JAWS INSERT EXPERIENCED AN OUT OF BOX FAILURE. ACCORDING TO THE INITIAL REPORTER, THE GRASPING FORCEPS HAD MISALIGNED JAWS NOTED DURING THE INITIAL USE OF THE DEVICE. THERE WAS NO PATIENT HARM REPORTED AS A RESULT OF THIS EVENT

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17765033 ↗