MAUDE Adverse Event Report: KARL STORZ SE & CO. KG COAGULATING AND DISSECTING ELECTRODE

Model Number	26775C
Medical Device Problem Codes	Mechanical Problem (1384); Defective Component (2292); Material Integrity Problem (2978); Temperature Problem (3022)
Health Effect - Clinical Code	Insufficient Information (4580)
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the insulation does not hold.It cracked.Current escapes from the sides.No negative impact in state of health reported.
Additional Manufacturer Narrative
The device in question was returned to the manufacturer.This information is reflected in section d9.The evaluation is anticipated, but not yet begun.The investigation will be performed by a designated karl storz employee.The event is filed under internal karl storz complaint id: (b)(4).
Additional Manufacturer Narrative
The device in question (26775c, coagulating and dissecting electrode, lot sn04, manufactured 30-may-2022) was received by the manufacturing site in germany on 08-jul-2025 for investigation.The examination of the claimed item 26775c and the information provided by the user clearly indicate that the electrode at the distal end has suffered significant thermal damage.The significant charring of the tip is a typical indication of excessive heat exposure, which may have been caused either by activation for too long or by the use of a peak voltage exceeding the specifications.According to the instructions for use, the product is designed for a maximum recurring peak voltage of 3.0 kvp and is intended exclusively for short-term coagulation applications.Activating the electrode for longer than intended or operating it at too high a voltage can lead to overheating and, as a result, thermal damage to the tip.In such cases, even after deactivation, the electrode may still be so hot that it can cause tissue burns.The findings are therefore consistent with a possible operating or application error.However, no production or material-related defect could be identified.The most likely cause of the described effect ("insulation does not hold/is torn, current escapes from the side") is therefore overuse of the product in clinical use and not a defective or faulty product.The event is filed under internal karl storz complaint id: (b)(4).

• Brand Name: COAGULATING AND DISSECTING ELECTRODE
• Common Device Name: COAGULATING AND DISSECTING ELECTRODE
• 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: 22701307
• Report Number: 9610617-2025-01346
• Device Sequence Number: 21091684
• Product Code: GEI
• UDI-Device Identifier: 04048551072288
• UDI-Public: 04048551072288
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K944796
• 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,User Facility,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 03/20/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 26775C
• Device Catalogue Number: 26775C
• Device Lot Number: SN04
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/08/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/17/2025
• Supplement Date Received by Manufacturer: 03/03/2026
• Initial Report FDA Received Date: 08/04/2025
• Supplement Report FDA Received Date: 03/20/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Is the Device Labeled for Single Use? (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
• Patient Sex: Unknown