Olympus WA64700ARecalls & reported problems

Summary

The FDA's MAUDE database contains 10 adverse event reports that list this exact device (DI 04042761031097), received between May 19, 2021 and Sep 2, 2026 — classified as 2 injuries, 8 malfunctions.

The most frequently reported specific device problem is “Break” (3 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 10 most recent of 10 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 2, 2026Break

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50572729 ↗
• MalfunctionDec 30, 2025Material Deformation; Material Deformation

  NO ADDITIONAL INFORMATION RECEIVED FROM THE CUSTOMER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23920562 ↗
• MalfunctionFeb 24, 2025Deformation Due to Compressive Stress; Deformation Due to Compressive Stress

  IT WAS REPORTED THAT THERE WAS BENDING OF THE TIP. THE ISSUE WAS FOUND UPON INSTALLATION. THERE WERE NO REPORTS OF PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21446842 ↗
• InjuryMar 8, 2024Break; Detachment of Device or Device Component; Break; Detachment of Device or Device Component

  IT WAS REPORTED DURING A THERAPEUTIC LAPAROSCOPIC COLECTOMY, WHILE USING THE REUSABLE NEEDLE HOLDER, THE TIP BROKE AND FELL INTO THE PATIENT'S ABDOMINAL CAVITY. WHAT APPEARED TO BE FALLEN PIECES WERE COLLECTED. THE DEVICE WAS REPLACED AND THE PROCEDURE WAS COMPLETED. AN ADDITIONAL COMPUTED TOMOGRAPHY (CT) SCAN WAS PERFORMED TO CHECK FOR ANY REMAINING FRAGMENTS, BUT NONE COULD BE FOUND. THE SURGICAL TIME WAS INCREASED BY APPROXIMATELY 30 MINUTES OR MORE. THERE WAS NO REPORTED PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18864716 ↗
• MalfunctionFeb 19, 2024Material Twisted/Bent; Material Twisted/Bent

  IT WAS REPORTED THAT THE JAWS "HIQ+", 5 X 330 MM, NEEDLE HOLDER GRIP, AT THE TIP, WAS BENT. THE ISSUE OCCURRED DURING PREPARATION FOR USE. THERE WERE NO REPORTS OF PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18735522 ↗
• MalfunctionFeb 9, 2024Component Missing; Component Missing

  IT WAS REPORTED, THE REUSABLE NEEDLE HOLDER JAWS WERE MISSING. THE ISSUE OCCURRED DURING REPROCESSING. THERE WERE NO REPORTS OF PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18681299 ↗
• MalfunctionDec 8, 2023Material Deformation; Material Deformation

  AN OLYMPUS EMPLOYEE REPORTED ON BEHALF OF A CUSTOMER, DURING A SURGERY, THE GRASPING PART AT THE TIP OF NEEDLE HOLDER INSERT WAS BENT TO THE RIGHT. THE ISSUE WOULD NOT ALLOW FOR THE SUBJECT DEVICE TO PERFORM IN THE MANNER THEY WERE AIMING FOR. THE UNSPECIFIED THERAPEUTIC PROCEDURE WAS COMPLETED WITHOUT HAVING TO CHANGE THE SUBJECT DEVICE. THERE WAS NO REPORT OF PATIENT HARM ASSOCIATED WITH THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18297809 ↗
• MalfunctionDec 29, 2022Detachment of Device or Device Component; Detachment of Device or Device Component

  THE CUSTOMER CONTACTED THE OLYMPUS TECHNICAL ASSISTANCE CENTER (TAC), TO REPORT THE DISTAL JAW NON ARTICULATING JAW BROKE OFF AND FELL INTO THE PATIENT DURING A ROBOTICS LAPAROSCOPIC PROCTECTOMY. THE CUSTOMER RETRIEVED THE PIECE THAT BROKE OFF AND COMPLETED THE PROCEDURE. NO PATIENT INJURY WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16074477 ↗
• MalfunctionApr 19, 2022Material Separation; Material Separation

  THE CUSTOMER REPORTS, DURING AN UNSPECIFIED DIAGNOSTIC PROCEDURE USING A JAWS ("HIQ+", 5 X 330 MM, NEEDLE HOLDER, STRAIGHT), THE TIP OF THE DEVICE BROKE OFF AND INTO THE PATIENT. IT IS UNKNOWN IF/HOW THE DEVICE FRAGMENT WAS RETRIEVED. IT IS UNKNOWN WHERE IN THE PATIENT'S BODY THE DEVICE FRAGMENT FELL. IT IS REPORTED THERE WAS HARM TO THE PATIENT, NO FURTHER DETAILS WERE PROVIDED. ADDITIONAL INFORMATION HAS BEEN REQUESTED. AT THIS TIME, NO FURTHER DETAIL HAS BEEN PROVIDED.

  Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions

  MAUDE report 14140190 ↗
• InjuryMay 19, 2021Break; Fracture; Material Fragmentation; Mechanical Problem; Adverse Event Without Identified Device or Use Problem; Break; Fracture; Material Fragmentation; Mechanical Problem; Adverse Event Without Identified Device or Use Problem

  OLYMPUS WAS INFORMED THAT DURING A THERAPEUTIC LAPAROSCOPIC HYSTERECTOMY PROCEDURE, THE TIP OF THE NEEDLE SNAPPED AND FELL INTO THE PATIENT¿S ABDOMEN. X-RAYS WERE PERFORMED ON THE TABLE AND THE FRAGMENT WAS RETRIEVED WITH THE ASSISTANCE OF THE GENERAL SURGEON. THE PATIENT HAD TO BE KEPT UNDER ANESTHETICS FOR MORE THAN THREE HOURS. NO FURTHER INFORMATION WAS PROVIDED BUT THERE WAS NO REPORT ABOUT A MALFUNCTION OF AN OLYMPUS MEDICAL DEVICE.

  Patient problems: Insufficient Information

  MAUDE report 11846864 ↗