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

Model Number	26775C
Medical Device Problem Codes	Mechanical Problem (1384); Overheating of Device (1437); Excessive Heating (4030)
Health Effect - Clinical Code	Burn(s) (1757)
Type of Reportable Event	Serious Injury
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).
Event or Problem Description
According to the information received, skin burns during surgery.As there is no more precise information about the burning degree the case is deemed reportable.
Additional Manufacturer Narrative
Correction is made in section b4.The submission date of this report was incorrect in the initial report.The event is filed under internal karl storz complaint id: (b)(4).
Additional Manufacturer Narrative
Result of investigation: the present case concerns a complaint in which, according to the user, skin burns occurred during an operation.After evaluating the information provided by the customer and examining the affected item 26775c, the most likely cause could be determined.The inspection of the item shows that the electrode at the distal end is severely charred.This indicates excessive heat exposure.The most likely reason for this is that the electrode was either activated for too long or operated at too high a voltage.According to the instructions for use, the product is designed for a recurring peak voltage of max.3.0 kvp and is intended exclusively for short-term coagulation.Prolonged activation or exceeding the maximum permissible voltage can lead to thermal damage to the electrode tip.As a result, the electrode may still be hot enough to cause skin burns even after deactivation.It should also be noted that item 34310ma - a scissor insert - is operated without hf (high frequency) and therefore cannot cause skin burns itself.For skin damage to occur, the hf electrode must have been actively used.This confirms the suspicion of a possible 26775c operating error or application error.Based in the information available, the product responsible for the incident is most likely the art.No.: 26775c.Therefore, the following investigation is solely for this product.The other product, 34310ma is collateral damage and most likely didn't contribute to the event at all.The breakage of the ceramic tip is most likely due to external forces combined with an inadequate visual inspection.As clearly described in the instructions for use, the shaft and ceramic tip must be checked for damage such as cracks or chips before each use.Failure to comply with this instruction may significantly impair the safety and function of the instrument.It can be assumed that the incident was caused by incorrect use.There is no technical defect or product fault.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: 22031683
• Report Number: 9610617-2025-00849
• Device Sequence Number: 8260797
• 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,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 08/05/2025

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: 26775C
• Device Catalogue Number: 26775C
• Device Lot Number: SN04
• 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: 04/28/2025
• Supplement Date Received by Manufacturer: 04/28/2025; 08/01/2025
• Initial Report FDA Received Date: 05/15/2025
• Supplement Report FDA Received Date: 05/16/2025; 08/05/2025
• 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: Reuse
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: MATERIAL: 34310MA, LOT: WM09.
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown