Olympus WA64710ARecalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 04042761031073), received between Aug 13, 2018 and Aug 27, 2026 — classified as 1 injury, 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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 27, 2026Break

  It was reported that the reusable Suturing needle holder was delivered with a broken tip. The malfunction was identified during installation. There were no reports of patient involvement.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50483684 ↗
• MalfunctionApr 30, 2026Break

  THE CUSTOMER DID NOT REPORT A MALFUNCTION. DURING ONSITE INSPECTION OF THE REUSABLE SUTURING NEEDLE HOLDER, BROKEN JAWS WERE FOUND. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25050606 ↗
• MalfunctionMar 17, 2026Loose or Intermittent Connection

  IT WAS REPORTED THE SUTURING NEEDLE HOLDER IS LOOSE AND DOES NOT HOLD THE NEEDLE. THE ISSUE OCCURRED DURING INSPECTION FOR USE. THERE WERE NO REPORTS OF PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24616853 ↗
• MalfunctionMay 20, 2025Break; Break

  IT WAS REPORTED THE SUBJECT DEVICE'S NEEDLE HOLDER WAS NOT WORKING. THE JAW WAS NOT HOLDING PROPERLY DUE TO A BROKEN JAW HINGE. THE ISSUE OCCURRED AT SERVICE/MAINTENANCE, NOT IN A CLINICAL SETTING. THERE WERE NO REPORTS OF PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22055689 ↗
• InjuryAug 6, 2024Break; Detachment of Device or Device Component; Break; Detachment of Device or Device Component

  IT WAS REPORTED, DURING A PROCEDURE. WHILE SUTURING, WITH THE NEEDLE HOLDER. A PIECE OF THE TIP FELL OFF, WHILE STILL IN THE PERITONEUM. AFTER RETRIEVING THE HAND INSTRUMENT, THE NURSE REALIZED, THAT THERE WAS A PIECE MISSING. AFTER THEY TRIED TO FIND THE PIECE INSIDE THE PATIENT AND DID NOT SUCCEED, THEY TOOK THE PATIENT OUT TO X-RAY. AFTER THEY FOUND WHERE THE TIP WAS, THEY MADE A REVISION AND TOOK IT OUT. THE PATIENT WAS REPORTED TO BE OKAY AND NOT IN A LIFE THREATENING CONDITION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19919150 ↗
• MalfunctionApr 7, 2023Break; Break

  THE CUSTOMER REPORTED TO OLYMPUS, THE JAWS "HIQ+", 5 X 330 MM, NEEDLE HOLDER, CURVED WAS BROKEN. THE ISSUE WAS FOUND DURING RECEIPT INSPECTION. THE PROCEDURE WAS COMPLETED WITH A SIMILAR DEVICE. THERE WERE NO REPORTS OF PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16701274 ↗
• MalfunctionAug 13, 2018Break; Fracture; Material Fragmentation; Mechanical Problem; Break; Fracture; Material Fragmentation; Mechanical Problem

  OLYMPUS WAS INFORMED THAT DURING A THERAPEUTIC APPENDECTOMY PROCEDURE, THE JAWS OF THE NEEDLE HOLDER BROKE AND A FRAGMENT FELL INSIDE THE PATIENT'S BODY CAVITY. HOWEVER, NO FRAGMENT REMAINED INSIDE THE PATIENT SINCE IT WAS REPORTEDLY RETRIEVED. THE INTENDED PROCEDURE WAS SUCCESSFULLY COMPLETED USING A SIMILAR DEVICE AND THERE WAS NO REPORT ABOUT AN ADVERSE EVENT OR PATIENT INJURY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7776234 ↗