Olympus WA51181LRecalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 04042761052641), received between Jun 3, 2019 and Aug 22, 2025 — classified as 3 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.

• 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 22873161 ↗
• MalfunctionAug 27, 2019Break; Fracture; Material Fragmentation; Break; Fracture; Material Fragmentation

  OLYMPUS WAS INFORMED THAT DURING REPROCESSING AFTER AN UNSPECIFIED LAPAROSCOPIC PROCEDURE, IT WAS NOTICED THAT A BLACK PART ON THE VALVE TUBE¿S WATER SUPPLY SIDE WAS MISSING. IT IS UNKNOWN WHETHER A FRAGMENT OF THE MISSING PART MAY HAVE GOTTEN INTO THE PATIENT¿S BODY DURING THE PROCEDURE AND IF YES, WHETHER IT REMAINED INSIDE THE PATIENT. NO FURTHER INFORMATION WAS PROVIDED. THE INTENDED PROCEDURE WAS COMPLETED SUCCESSFULLY WITH THE SAME SET OF EQUIPMENT AND THERE WAS NO REPORT ABOUT AN ADVERSE EVENT OR PATIENT INJURY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8934927 ↗
• MalfunctionJun 3, 2019Break; Fracture; Material Fragmentation; Mechanical Problem; Break; Fracture; Material Fragmentation; Mechanical Problem

  OLYMPUS WAS INFORMED THAT AFTER AN UNSPECIFIED THERAPEUTIC PROCEDURE, IT WAS NOTICED THAT THE IRRIGATION CONNECTOR OF THE VALVE TUBING WAS DAMAGED AND THAT FRAGMENTS HAD BROKEN OFF. IT IS UNKNOWN WHEN THIS DAMAGE OCCURRED AND WHETHER ANY FRAGMENTS WERE POSSIBLY FLUSHED INTO THE PATIENT'S BODY CAVITY. HOWEVER, THE INTENDED PROCEDURE WAS SUCCESSFULLY COMPLETED WITH THE SAME SET OF EQUIPMENT AND THERE WAS NO ADVERSE EVENT OR PATIENT INJURY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8662597 ↗