Olympus WA51181SRecalls & reported problems
OLYMPUS Winter & Ibe GmbH · Valve tube, for HiQ+ handle, suction channel 5 mm, 1 pcs. · Class 2
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 04042761052658), received between May 7, 2018 and Aug 20, 2019 — classified as 2 malfunctions.
The most frequently reported specific device problem is “Material Fragmentation” (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
Device problems
- Material Fragmentation2
- Break1
- Detachment of Device or Device Component1
- Fracture1
Patient problems
- No Known Impact Or Consequence To Patient2
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionAug 20, 2019Material Fragmentation; Detachment of Device or Device Component; Material Fragmentation; Detachment of Device or Device Component
OLYMPUS WAS INFORMED THAT PRIOR TO CLEANING, AFTER AN UNSPECIFIED PROCEDURE, IT WAS NOTICED THAT THE SUCTION CONNECTOR OF THE VALVE TUBING WAS DAMAGED AND THAT A FRAGMENT HAD BROKEN OFF. IT IS UNKNOWN WHEN THIS DAMAGE OCCURRED AND WHETHER A FRAGMENT WAS POSSIBLY FLUSHED INTO THE PATIENT'S BODY CAVITY. NO FURTHER INFORMATION WAS PROVIDED AND THERE WAS NO REPORT ABOUT AN ADVERSE EVENT OR PATIENT INJURY.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 8909682 ↗MalfunctionMay 7, 2018Break; Fracture; Material Fragmentation; Break; Fracture; Material Fragmentation
OLYMPUS WAS INFORMED THAT DURING CLEANING, AFTER AN UNSPECIFIED THERAPEUTIC LAPAROSCOPIC PROCEDURE AT AN UNKNOWN DATE, IT WAS NOTICED THAT THE IRRIGATION CONNECTOR OF THE VALVE TUBING WAS DAMAGED. IT IS UNKNOWN WHEN THIS DAMAGE OCCURRED. 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 7489680 ↗
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Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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