Olympus WA69320MRecalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 04042761079297), received between May 16, 2018 and May 5, 2026 — classified as 2 injuries, 6 malfunctions.

The most frequently reported specific device problem is “Break” (6 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 8 most recent of 8 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 5, 2026Break

  IT WAS REPORTED THAT THE RIGID ENDOSCOPIC TISSUE MANIPULATION FORCEPS, REUSABLE HAD THE TIP OF THE DEVICE BENT AND FELL OFF . THE ISSUE WAS OBSERVED DURING AN UNSPECIFIED THERAPEUTIC PROCEDURE. THERE WERE NO REPORTS OF PATIENT HARM.

  Patient problems: Foreign Body In Patient

  MAUDE report 25084371 ↗
• MalfunctionJan 16, 2026Structural Problem

  THERE IS NO NEW INFORMATION PROVIDED BY THE CUSTOMER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24105062 ↗
• MalfunctionSep 21, 2023Break; Break

  THE CUSTOMER REPORTED TO OLYMPUS THAT ONE OF THE JAWS BROKE OFF DURING REPROCESSING. THERE WERE NO REPORTS OF PATIENT HARM OR IMPACT ASSOCIATED WITH THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17787612 ↗
• MalfunctionAug 2, 2023Material Deformation; Material Deformation

  THE CUSTOMER REPORTED THAT THE TIP OF JAWS WAS DISTORTED. THE ISSUE WAS DISCOVERED WHEN THE PRODUCT WAS PURCHASED. THERE WERE NO REPORTS OF PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17441757 ↗
• MalfunctionJul 3, 2023Break; Break

  THE CUSTOMER REPORTED THAT THE FORCEPS BROKE WITH A CRACKING SOUND. NO PARTS FELL OUT OF THE BODY. THE REPORTED ISSUE WAS OBSERVED DURING A THERAPEUTIC LAPAROSCOPY. THE INTENDED PROCEDURE WAS COMPLETED USING OTHER FORCEPS. THERE WAS NO PATIENT OR USER INJURY REPORTED DUE TO THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17248855 ↗
• InjuryJul 3, 2023Break; Break

  THE CUSTOMER REPORTED TO OLYMPUS THAT DURING AN UNSPECIFIED THERAPEUTIC SURGERY, THE TIP OF THIS FORCEPS BROKE AND FELL INTO THE PATIENT'S BODY. THE BROKEN PART WAS RECOVERED. THE PROCEDURE WAS COMPLETED WITH SIMILAR DEVICE. THERE WERE NO REPORTS OF FURTHER PATIENT OR USER HARM ASSOCIATED WITH THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17246550 ↗
• InjurySep 23, 2022Break; Fracture; Material Fragmentation; Mechanical Problem; Break; Fracture; Material Fragmentation; Mechanical Problem

  OLYMPUS WAS INFORMED THAT DURING REPROCESSING AFTER A THERAPEUTIC LAPAROSCOPIC ASCENDING COLECTOMY PROCEDURE, IT WAS NOTICED THAT A PART OF THE CURVED TIP AT THE DISTAL END OF THE JAWS INSERT WAS MISSING. CONSEQUENTLY, AN X-RAY EXAMINATION WAS PERFORMED AND THE MISSING FRAGMENT WAS LOCATED INSIDE THE PATIENT. AN ADDITIONAL SURGERY WAS CARRIED OUT AND THE BROKEN FRAGMENT WAS SUCCESSFULLY RETRIEVED.

  Patient problems: Foreign Body In Patient

  MAUDE report 15474573 ↗
• MalfunctionMay 16, 2018Break; Fracture; Material Fragmentation; Mechanical Problem; Break; Fracture; Material Fragmentation; Mechanical Problem

  OLYMPUS WAS INFORMED THAT DURING A THERAPEUTIC COLONOSCOPY PROCEDURE, THE JAWS AT THE DISTAL END OF THE SUSPECT MEDICAL DEVICE BROKE WHILE GRIPPING THE LARGE INTESTINE AND A FRAGMENT FELL INSIDE THE PATIENT. HOWEVER, NO FRAGMENT REMAINED INSIDE THE PATIENT SINCE IT WAS REPORTEDLY RETRIEVED. THE INTENDED PROCEDURE WAS SUCCESSFULLY COMPLETED WITH THE SAME SET OF EQUIPMENT AND THERE WAS NO REPORT ABOUT AN ADVERSE EVENT OR PATIENT INJURY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7517541 ↗