MAUDE Adverse Event Report: KARL STORZ SE & CO. KG COAGULATION ELECTRODE

Model Number	24515
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/12/2025
Type of Reportable Event	Malfunction
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
It was reported the surgeon was using the product during an epsit procedure.The scrub nurse and consultant asked mid case if the coagulation end should come away from the insulation.It was said no and advised to open another set to use a second electrode, but surgeon didn't think it was worth opening a new set for.The case was finished.No death or (unanticipated) serious deterioration in state of health reported.
Additional Manufacturer Narrative
The device in question was returned to the manufacturer on march 28,2025.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
Device evaluation: the customer's description of the fault can be confirmed: the insulation has retracted slightly at the distal end or has worn due to the expected number of applications over time.Since the article is already 6 years old.The event is filed under internal karl storz complaint id: (b)(4).

• Brand Name: COAGULATION ELECTRODE
• Common Device Name: COAGULATION 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: 21704069
• Report Number: 9610617-2025-00510
• Device Sequence Number: 13279967
• Product Code: GEI
• UDI-Device Identifier: 04048551263747
• UDI-Public: 04048551263747
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• 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): 07/17/2025

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: 24515
• Device Catalogue Number: 24515
• Device Lot Number: OQ01
• 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: 03/12/2025
• Supplement Date Received by Manufacturer: 03/28/2025; 06/24/2025
• Initial Report FDA Received Date: 03/26/2025
• Supplement Report FDA Received Date: 04/15/2025; 07/17/2025
• 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