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
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.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 f10 medical device problem reported and other findings would not cause or contribute to a death or a serious injury if it were to recur.

• 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
• MDR Report Key: 21168244
• Report Number: 2429304-2025-00033
• Device Sequence Number: 17206379
• Product Code: GEI
• UDI-Device Identifier: 14042761085875
• UDI-Public: 14042761085875
• Combination Product (Y/N): N
• Initial Reporter State: SD
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Importer
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 05/28/2025
• Report Date (Section F): 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
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 05/28/2025
• Event Location: Hospital
• Date Report to Manufacturer: 12/17/2024
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 01/16/2025
• Supplement Report FDA Received Date: 05/28/2025
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: A
• Patient Sequence Number: 1
• Patient Sex: Unknown
• Date Report Sent to FDA: 05/28/2025