MAUDE Adverse Event Report: OLYMPUS WINTER & IBE GMBH VALVE TUBE, FOR HIQ+ HANDLE, SUCTION CHANNEL 8 MM, 1 PCS.; WA51181L

Model Number	WA51181L
Medical Device Problem Codes	Obstruction of Flow (2423); Poor Visibility (4072)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/30/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The investigation is ongoing.A supplemental report will be submitted when the investigation is completed or if additional information becomes available.
Event or Problem Description
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.
Additional Manufacturer Narrative
This supplemental report is being submitted to provide the results of the final investigation.Updates fields: b5, d9, g3, h2, h3, h6 and h11.The device was returned to olympus for inspection.Based on the results of the investigation the customer allegation was confirmed.The irrigation/suction tube was attached and upon pressing on the irrigation/suction levers it was confirmed that the suction lever was stuck and not retracting back into its normal position.It was likely due to a component problem.Olympus will continue to monitor field performance for this device.
Event or Problem Description
No additional information received from customer.

• Brand Name: VALVE TUBE, FOR HIQ+ HANDLE, SUCTION CHANNEL 8 MM, 1 PCS.
• Common Device Name: WA51181L
• 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 ; 5082077661
• MDR Report Key: 22873161
• Report Number: 9610773-2025-05284
• Device Sequence Number: 10386865
• Product Code: GCJ
• UDI-Device Identifier: 04042761052641
• UDI-Public: 04042761052641
• Combination Product (Y/N): N
• PMA/510(K) Number: K923982
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 03/03/2026

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: Other
• Device Model Number: WA51181L
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 07/25/2025
• Supplement Date Received by Manufacturer: 02/27/2026
• Initial Report FDA Received Date: 08/22/2025
• Supplement Report FDA Received Date: 03/03/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/09/2023
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown