MAUDE Adverse Event Report: KARL STORZ SE & CO. KG ELECTRODE,BIPOLAR,CUTTING LOOP

Model Number	011160-10
Medical Device Problem Code	Sparking (2595)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/03/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device in question was returned to the manufacturer on march 6, 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.Cross reference complaint id: (b)(4).The event is filed under internal karl storz complaint id: (b)(4).
Event or Problem Description
It was reported that during surgery sparks of fire came out of the working element and the cable.No harm for the patient or the surgeon.The surgery was prolonged for less than 15 minutes.No negative impact in state of health reported.Cross reference mdr: 9610617-2025-00553; 9610617-2025-00555.
Additional Manufacturer Narrative
Additional information added in section d-4: udi number and g-4 :510k number.The event is filed under internal karl storz complaint id: (b)(4).
Additional Manufacturer Narrative
Device evaluation: during the technical inspection of the returned product, the following was found: the bipolar hf-cable did not perform as intended as it has burnt through at the plug on the instrument side.Therefore, the cable is considered as the leading device which led to the reported error pattern.It was reported that during surgery sparks of fire' came out of the working element and the cable.The bipolar hf-cable is not manufactured and only distributed by karl storz.The bipolar hf-cable is labeled "erbe ref 20196-118".A definitive root cause is not possible as the hf-cable is not a karl storz product.Molten residues of the burnt cable can be seen on the entire contact surface of the working element.The karl storz electrode, bipolar was not causative for the defect and is therefore not further considered.A labeling review for the bipolar hf-cable is not possible as karl storz is not the legal manufacturer of this product and therefore has no technical specifications as e.G.Inspection lot and instruction for use.The event is filed under internal karl storz complaint id: (b)(4).

• Brand Name: ELECTRODE,BIPOLAR,CUTTING LOOP
• Common Device Name: ELECTRODE,BIPOLAR,CUTTING LOOP
• 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: 21780656
• Report Number: 9610617-2025-00554
• Device Sequence Number: 20991591
• Product Code: FAS
• UDI-Device Identifier: 04048438005408
• UDI-Public: 04048438005408
• Combination Product (Y/N): N
• Initial Reporter Country: BE
• PMA/510(K) Number: K221893
• 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): 11/11/2025

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: 011160-10
• Device Catalogue Number: 011160-10
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/06/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/06/2025
• Supplement Date Received by Manufacturer: 05/13/2025; 11/07/2025
• Initial Report FDA Received Date: 04/04/2025
• Supplement Report FDA Received Date: 05/13/2025; 11/11/2025
• 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