MAUDE Adverse Event Report: KARL STORZ SE & CO. KG WORKING ELEMENT, BIPOLAR

Model Number	26050CA
Medical Device Problem Code	Unintended Electrical Shock (4018)
Health Effect - Clinical Codes	Electric Shock (2554); Convulsion/Seizure (4406)
Date of Event	01/07/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The affected device has been requested for investigation.However, the manufacturer was informed that the device will not be returned for investigation.The event is filed under internal karl storz complaint id: (b)(4).
Event or Problem Description
It was reported that leakage occurred for the third time in the use of electric endoscopic instruments in the operation by user, and shocked the patient, but only convulsed during the operation, causing no serious injury, and there was no intervention treatment in the later stage.It was confirmed that the procedure was completed successfully and there was no further impact or consequences.However, due to the reported shock and convulsion of the patient this case is deemed reportable for precautionary reasons.

• Brand Name: WORKING ELEMENT, BIPOLAR
• Common Device Name: WORKING ELEMENT, BIPOLAR
• Manufacturer (Section D): KARL STORZ SE & CO. KG; dr.-karl-storz-strasse 34; tuttlingen, 78532 ; GM 78532
• MDR Report Key: 21287062
• Report Number: 2020550-2025-00099
• Device Sequence Number: 15782888
• Product Code: HIH
• UDI-Device Identifier: 04048551007228
• UDI-Public: 04048551007228
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Importer
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 01/31/2025
• Report Date (Section F): 01/31/2025

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?: Yes
• Operator of Device: Health Professional
• Device Model Number: 26050CA
• Device Catalogue Number: 26050CA
• Device Lot Number: ZN03
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 01/30/2025
• Event Location: Hospital
• Date Report to Manufacturer: 01/31/2025
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 01/31/2025
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown