Olympus WA64121CRecalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 04042761063487), received between Sep 1, 2023 and Sep 1, 2023 — classified as 1 injury.

The most frequently reported specific device problem is “Break” (1 report).

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 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• InjurySep 1, 2023Break; Detachment of Device or Device Component; Break; Detachment of Device or Device Component

  A CUSTOMER REPORTED TO OLYMPUS THAT WHILE USING A JAWS "HIQ+", BIPOLAR, 5 X 430 MM, GRASPING FORCEPS, FENESTRATED, LONG, FOR AN UNSPECIFIED LAPAROSCOPIC PROCEDURE, THE FIXED UNIT CONNECTING THE SLEEVE ROD AND THE JAW FELL OFF. IT WAS LATER CLARIFIED THAT THE JAW OF THE FORCEPS BROKE AND FELL INTO THE PATIENT¿S BODY AND WAS REMOVED AFTER LOCALIZATION BY X-RAY. THE PROCEDURE WAS FINISHED WITH A SIMILAR DEVICE. THERE WAS NO ADDITIONAL PATIENT INJURY OR HEALTH DAMAGE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17670289 ↗