MAUDE Adverse Event Report: OLYMPUS WINTER & IBE GMBH NEUTRAL ELECTRODE, UNIVERSAL SIZE, WITHOUT CABLE; WA99516A

Model Number	WA99516A
Medical Device Problem Code	Activation Failure (3270)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/17/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
This report has been submitted by the importer under this mdr report number 2429304-2025-00033.The event was conservatively classified as a serious injury due to the procedure allegedly being prolonged by 30 or more minutes.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 during a polypectomy procedure, the cautery could not be applied with the use of the subject device.This resulted to the delay of the procedure for more than 30 minutes while the patient was under sedation.It was then completed with the use of a competitor device.There were no reports of adverse patient sequelae.
Event or Problem Description
Additional information was received from the customer confirmed that there was no evidence the patient suffered any serious injury or adverse effects from the prolonged procedure.
Additional Manufacturer Narrative
This report has been submitted by the importer under this mdr report number 2429304-2025-00033-01.This supplemental report is being submitted to provide correction, additional information from the customer and the results of the legal manufacturer¿s investigation.This event was initially conservatively reported as a serious injury; however, upon further follow-up, the customer confirmed that the patient did not suffer any serious injury or adverse effects from the prolonged procedure, thus correcting b1, b2, and h1.B1 should not be marked as an adverse event, and b2 should not be marked at all.H1 should also not be marked.The h6 medical device problem reported and other findings would not cause or contribute to a death or a serious injury if it were to recur.The device was returned to olympus for inspection and the reported failure was not confirmed.A functional test could not be performed as the neutral electrodes that were returned did not provide the cable for testing.A definitive root cause could not be identified.Based on the results of the investigation, the most probable cause was not established; the investigation findings do not lead to a clear conclusion about the cause of the reported adverse event.Should additional relevant information become available, a supplemental report will be submitted.Olympus will continue to monitor field performance for this device.

• Brand Name: NEUTRAL ELECTRODE, UNIVERSAL SIZE, WITHOUT CABLE
• Common Device Name: WA99516A
• 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: 21168254
• Report Number: 9610773-2025-00468
• Device Sequence Number: 14587279
• Product Code: GEI
• UDI-Device Identifier: 14042761085875
• UDI-Public: 14042761085875
• Combination Product (Y/N): N
• Initial Reporter State: SD
• Initial Reporter Country: US
• PMA/510(K) Number: K173877
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 05/28/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Model Number: WA99516A
• Device Lot Number: 314-576
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 12/17/2024
• Supplement Date Received by Manufacturer: 05/16/2025
• Initial Report FDA Received Date: 01/16/2025
• Supplement Report FDA Received Date: 05/28/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/03/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown