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

Model Number	26775UE
Medical Device Problem Codes	Detachment of Device or Device Component (2907); Material Split, Cut or Torn (4008)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Event or Problem Description
The following was reported "during the setup of the operating cart for laparoscopic procedure, the instrument nurse found an abnormality on the instrument in use: the insulating cover of the coagulating and dissecting electrode showed obvious signs of damage.In particular, the insulation was visibly deteriorated, no longer smooth nor uniform, as if it had partially melted and detached, starting from the upper end and descending toward the lower part of the electrode., the device has been removed from the operating room.There is no information that the event caused a harm or serious injury to patient, user or third.
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
Additional information is provided in section d9 to reflect that the product was returned for evaluation.The investigation is not completed yet.The investigation results are pending.The event is filed under internal karl storz complaint id: (b)(4).
Additional Manufacturer Narrative
Device evaluation: during the investigation of the returned product, the following was found: the customer's complaint: "the insulating cover of the coagulating and dissecting electrode showed obvious signs of damage.In particular, the insulation was visibly deteriorated, no longer smooth nor uniform, as if it had partially melted and detached, starting from the upper end and descending toward the lower part of the electrode" can be confirmed.It was determined that the shrink connection of the insulation had come loose and could be moved on the shaft (with force).When removing the insulation, considerable residues were found under the insulation, some of which had migrated under the insulation.Most probably the insulation contracted due to an excessively hot electrode tip and thus detached from the rest of the shaft.The end of the product life is largely determined by wear, reprocessing processes, the chemicals used and any damage resulting from use.The item was produced in 2021 it can be concluded that the device has undergone many reprocessing cycles and applications.Thus the damage is caused due to normal wear and tear.The corresponding instructions for use 26775ue_en_v47.2_03-2023_ri_ce states in chapter 8 visual inspection that the product must be checked for damage and to discard any items that appear damaged.This event is filed under internal 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: 21998247
• Report Number: 9610617-2025-00827
• Device Sequence Number: 18512724
• 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,User Facility,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 11/19/2025

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: 26775UE
• Device Catalogue Number: 26775UE
• Device Lot Number: WO01
• 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: 04/23/2025
• Supplement Date Received by Manufacturer: 05/14/2025; 11/17/2025
• Initial Report FDA Received Date: 05/09/2025
• Supplement Report FDA Received Date: 06/23/2025; 11/19/2025
• 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
• Patient Sex: Unknown