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

Model Number	26050CA
Medical Device Problem Codes	Leak/Splash (1354); 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.
Additional Manufacturer Narrative
Additional information: the product concerned (material-no: 26050ca, lot: zn03) was not returned for investigation.Therefore, it is not possible to investigate the exact cause.It was reported that the product is leaking, but it is unclear where it is leaking.Potential scenarios could be that the shaft was damaged by the user or had previously been repaired by a third-party company.The event is filed under internal karl storz complaint id: (b)(4).

• 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
• Manufacturer (Section G): KARL STORZ SE & CO. KG; dr.-karl-storz-strasse 34; tuttlingen, 78532 ; GM 78532
• Manufacturer Contact: anja fair ; 2151 e grand ave; el segundo, CA 90245
• MDR Report Key: 21287065
• Report Number: 9610617-2025-00099
• Device Sequence Number: 9320130
• Product Code: HIH
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K221893
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 05/12/2026

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
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/15/2025
• Supplement Date Received by Manufacturer: 04/16/2026
• Initial Report FDA Received Date: 01/31/2025
• Supplement Report FDA Received Date: 05/12/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown