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

Model Number	26775UE
Medical Device Problem Code	Material Split, Cut or Torn (4008)
Health Effect - Clinical Code	Bowel Burn (1756)
Date of Event	03/12/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that during laparoscopic surgery, a malfunction of the cautery device has been reported, due to an incompleted shielding, which caused damages to the rectum, out from the operative field.In particular, malfunctioning is related to a small breach in the protective coating of the device, located at 10 cm upstream of the distal end.That caused a lateral current discharge during electrical dissection.[this] resulted in damage at rectum level.The patient has been discharged without any permanent damage, as a result of the event.The burn, caused by the device, affected an intestine section, which was removed during surgery.The removal of the affected intestinal part was necessary for the successful outcome of the surgery and was not related directly to the burn.
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
The device in question was returned to the manufacturer.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
During investigation of the returned product (26775ue coagulating and dissecting electrode, lot: sl01) an interruption (damage) in the insulation could be found approximately 10cm before the distal end of the electrode.It is concluded that this allowed current to escape at this point during use, causing burns to the tissue.The damage to the insulation could most likely have been caused, for example, by improper handling (e.G.Contact with sharp objects during preparation or in the operating room).The production and test documents did not show any abnormalities.The instructions for use include a warning which states to ensure that the electrodes are in good working order before each use, to check the insulation for any damage and if there are any signs of damage the electrode must not be used under an circumstances.In addition, the reprocessing instructions state to check the surface of the product for mechanical integrity and changes.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: 21766672
• Report Number: 9610617-2025-00548
• Device Sequence Number: 18327549
• Product Code: GEI
• UDI-Device Identifier: 04048551072394
• UDI-Public: 04048551072394
• Combination Product (Y/N): N
• Initial Reporter Country: IT
• 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): 08/06/2025

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: 26775UE
• Device Catalogue Number: 26775UE
• Device Lot Number: SL01
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/21/2025
• Supplement Date Received by Manufacturer: 05/14/2025; 08/04/2025
• Initial Report FDA Received Date: 04/03/2025
• Supplement Report FDA Received Date: 05/28/2025; 08/06/2025
• 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: Unknown
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown