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

Model Number	26040EB
Medical Device Problem Codes	Device Handling Problem (3265); Unintended Electrical Shock (4018)
Health Effect - Clinical Codes	Electric Shock (2554); Convulsion/Seizure (4406)
Date of Event	12/13/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that leakage occurred 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
The affected device has been requested for investigation by the manufacturer.The device was not yet returned for investigation.The event is filed under internal karl storz complaint id: (b)(4).
Additional Manufacturer Narrative
Result of investigation: as the device in question was not returned by the customer, a physical investigation of the product itself could not be performed.However, the available information has been reviewed.Without product it is not possible to determine an exact cause.Customer describes that it was leaking during the operation.The most probable root cause is the wear of the loop material due to high voltage power provided by the high frequency unit.This in turn leads the cable plug to a high resistance which forces the insulation to melt.Traces of soot on the working element are merely signs of this defect, triggered by the high-frequency voltage.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: 21287055
• Report Number: 9610617-2025-00097
• Device Sequence Number: 9320125
• Product Code: HIH
• UDI-Device Identifier: 04048551091784
• UDI-Public: 04048551091784
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K221893
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• 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): 01/14/2026

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: 26040EB
• Device Catalogue Number: 26040EB
• Device Lot Number: OM10
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/15/2025
• Supplement Date Received by Manufacturer: 12/15/2025
• Initial Report FDA Received Date: 01/31/2025
• Supplement Report FDA Received Date: 01/14/2026
• 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
• Concomitant Medical Products and Therapy/Usage Dates: ARTICLE: 26040GP1. LOT: UNKNOWN; ARTICLE: UH801 LOT: UNKNOWN
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown