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

Model Number	26775UF
Medical Device Problem Codes	Flaked (1246); Overheating of Device (1437); Use of Device Problem (1670)
Health Effect - Clinical Codes	Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/31/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Correction is provided in section g2.This event is filed under internal complaint id (b)(4).
Additional Manufacturer Narrative
The device was returned to our us facility on february 25, 2025.It will be forwarded to the manufacturing site for investigation.Should relevant additional information / investigation results become available, a supplemental medwatch report will be submitted unsolicited.Cross reference complaint id (b)(4), cross reference complaint id (b)(4).This event is filed under internal complaint id (b)(4).
Additional Manufacturer Narrative
It is unknown if the product will be returned for evaluation by the manufacturer.Should relevant additional information / investigation results become available, a supplemental medwatch report will be submitted unsolicited.Cross reference complaint id: (b)(4).Cross reference complaint id: (b)(4).This event is filed under internal complaint id: (b)(4).
Event or Problem Description
The event occurred in canada.It was reported: problem of insulation.No negative impact in state of health reported.Cross reference medwatch: 9610617-2025-00239, cross reference medwatch: 9610617-2025-00240.
Additional Manufacturer Narrative
Per investigation by the manufacturing site: the insulation on the hook on the distal side is badly damaged.The most probable root cause of this is that the insulation was damaged by the heal generated at the tip of the electrode.Another cause may be contact with sharp edges of other instruments.Cross reference complaint id (b)(4).Cross reference complaint id (b)(4).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, deu 78532 ,; GM 78532,
• Manufacturer (Section G): KARL STORZ SE & CO. KG; dr.-karl-storz-strasse 34; tuttlingen, deu 78532 ,; GM 78532,
• Manufacturer Contact: anja fair ; 2151 e. grand avenue; el segundo, CA 90245 ; 4242188247
• MDR Report Key: 21411725
• Report Number: 9610617-2025-00236
• Device Sequence Number: 21168359
• Product Code: GEI
• UDI-Device Identifier: 04048551072417
• UDI-Public: 04048551072417
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• 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: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 06/09/2025

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: 26775UF
• Device Catalogue Number: 26775UF
• 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: Not provided
• Supplement Date Received by Manufacturer: Not provided; 05/07/2025; 06/03/2025
• Initial Report FDA Received Date: 02/19/2025
• Supplement Report FDA Received Date: 03/03/2025; 05/08/2025; 06/09/2025
• 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