MAUDE Adverse Event Report: Olympus Winter & Ibe GmbH Handle "HiQ+", for suction/irrigation tube, valve; endoscopic suction valve, reusable

Model Number	WA51172A
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/28/2026
Type of Reportable Event	Malfunction
Event or Problem Description
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.
Additional Manufacturer Narrative
The device was not returned to olympus for inspection, and the reported failure was not confirmed.Olympus has not been able to confirm the malfunction at this time.The assessment is based on information provided by the customer only.Based on the results of the investigation, and since the device was not returned for evaluation, the definitive root cause of the reported issue could not be determined.Should additional relevant information become available, a supplemental report will be submitted.Olympus will continue to monitor field performance for this device.

• Brand Name: Handle "HiQ+", for suction/irrigation tube, valve
• Common Device Name: endoscopic suction valve, reusable
• Manufacturer (Section D): Olympus Winter & Ibe GmbH; kuehnstrasse 61; hamburg, hamburg 22045 ; GM 22045
• Manufacturer (Section G): Olympus Winter & Ibe GmbH; kuehnstrasse 61; hamburg, hamburg 22045 ; GM 22045
• Manufacturer Contact: todd brill ; 800 west park drive; westborough, MA 01581 ; +1(508)207-7661
• MDR Report Key: 50902654
• Report Number: 9610773-2026-06383
• Device Sequence Number: 10705962
• Product Code: GCJ
• UDI-Device Identifier: 04042761024402
• UDI-Public: 04042761024402
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K923982
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility
• Initial Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date (Section B): 09/25/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: WA51172A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Received by Manufacturer: 08/28/2026
• Initial Report FDA Received Date: 09/25/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Is the Device Labeled for Single Use? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: PS-0537CJDA POWERSEAL 5MM, 37CM, CURVED.; WA51138A Suction/irrigation tube HIQ+.; WA51181S Valve tube for HiQ.
• Patient Sex: Unknown