Olympus WA51172ARecalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 04042761024402), received between Aug 22, 2025 and Sep 25, 2026 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Fracture” (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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 25, 2026Fracture

  The customer reported that during a therapeutic stomach procedure, while the patient was under sedation and the Endoscopic Suction Valve was in use, a piece of metal was found in the patient's stomach. The metal fragment was retrieved. Based on the information provided, only a photograph of the retrieved metal fragment was included in the complaint file; however, the retrieval method and the tools used for retrieval were not provided. The customer has not identified where the piece came from, nor if the piece fell off from any device used in the procedure. During the procedure no Olympus device had any malfunction noted. Aspiration of a foreign object was suspected, and a preoperative X-ray was checked, but nothing suggestive was identified. The procedure was completed with the same device. There were no further reports of patient harm. This report is 2 of 4.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50902654 ↗
• MalfunctionAug 22, 2025Obstruction of Flow; Poor Visibility; Obstruction of Flow; Poor Visibility

  IT WAS REPORTED THAT THE SUBJECT DEVICE HAD THE SUCTION/IRRIGATOR HANDLE GETTING STUCK IN THE SUCTION POSITION DURING AN ABDOMINAL LAPAROSCOPIC PROCEDURE, CAUSING THE CO2 IN THE PATIENT'S ABDOMEN TO GET SUCKED OUT. THIS MADE THE SURGEONS LOSE VISIBILITY MULTIPLE TIMES. IT ALSO REDUCED SURGICAL EFFICIENCY AS THEY HAD TO KEEP PAUSING TO ALLOW THE ABDOMEN TO REINFLATE. THERE WAS MINIMAL DELAY TO THE LAPAROSCOPIC ROUX-EN-Y GASTRIC BYPASS PROCEDURE. THE DEVICE WAS REPLACED WITH A SIMILAR DEVICE. THERE WERE NO REPORTS OF PATIENT HARM OR SERIOUS INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22872947 ↗