Olympus WA60120ARecalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 04042761031066), received between May 6, 2019 and Sep 8, 2026 — classified as 1 injury, 2 malfunctions.

The most frequently reported specific device problem is “Break” (2 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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 8, 2026Fracture; Detachment of Device or Device Component

  During an unspecified procedure, the jaw of the needle holder broke and fell into the patient's abdomen. The device part was retrieved with no reports of further patient harm.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50665635 ↗
• InjurySep 4, 2019Break; Break

  THE SERVICE CENTER WAS INFORMED THAT DURING A LAPAROSCOPIC PARAESOPHAGEAL HERNIA REPAIR PROCEDURE, THE TIP OF THE NEEDLE DRIVER BROKE OFF INTO THE PATIENT¿S STOMACH. THE DOCTOR WAS ABLE TO LOCATE AND RETRIEVE THE DEVICE FRAGMENT BY NAVIGATING THROUGH THE PATIENT¿S PELVIS USING X-RAY (FLUOROSCOPY). THE INCIDENT LED TO AN INCREASED EXPOSURE TO ANESTHESIA. THE INTENDED PROCEDURE WAS COMPLETED WITH A SIMILAR DEVICE. THE PATIENT WAS NOT KEPT FOR OBSERVATION. THERE WAS NO LONG TERM AFFECT TO THE PATIENT.

  Patient problems: No Code Available

  MAUDE report 8961228 ↗
• MalfunctionMay 6, 2019Break; Break

  OLYMPUS WAS INFORMED THAT DURING A LAPAROSCOPIC ABDOMINAL HYSTERECTOMY, THE DOCTOR WAS INSERTING THE DEVICE INTO THE PATIENT'S ABDOMINAL CAVITY WHEN THE SURGEON NOTICED THE DISTAL PART OF THE "NEEDLE" BROKE OFF INSIDE THE PATIENT. THE SURGEON WAS NOT ABLE TO LOCATE THE DISTAL PART OF THE DEVICE IN THE PATIENT'S ABDOMINAL CAVITY. THE RESULTS OF THE PATIENT'S X-RAY DID NOT SHOW EVIDENCE OF ANY DEVICE FRAGMENTS INSIDE THE PATIENT'S ABDOMINAL CAVITY. THE INTENDED PROCEDURE WAS COMPLETED USING ANOTHER DEVICE. THERE WAS NO POST SURGERY COMPLICATIONS OR INJURIES REPORTED BY THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8583075 ↗