MAUDE Adverse Event Report: KARL STORZ SE & CO. KG WORKING ELEMENT

Model Number	26050E
Medical Device Problem Code	Sparking (2595)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/19/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The affected device has been requested for investigation by the manufacturer.Device was not returned at the time of mdr submission.The event is filed under internal karl storz complaint id: (b)(4).
Event or Problem Description
It was reported that the scrub team setting up the instrument, plugged in the karl storz diathermy cable into the working element when sparks occurred and a burning smell.The diathermy machine immediately switch off, the cable was then removed and both instruments placed to one side.Delay of procedure 15-30 minutes.No negative impact in state of health reported.
Additional Manufacturer Narrative
The device in question was returned to manufacturer.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
Correction in section h2 the event is filed under internal karl storz complaint id: (b)(4).

• Brand Name: WORKING ELEMENT
• Common Device Name: WORKING ELEMENT
• 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
• MDR Report Key: 23744787
• Report Number: 9610617-2025-02273
• Device Sequence Number: 15565607
• Product Code: HIH
• UDI-Device Identifier: 04048551092293
• UDI-Public: 04048551092293
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: K232486
• 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,User Facility,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 12/30/2025

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: 26050E
• Device Catalogue Number: 26050E
• 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: 11/20/2025
• Supplement Date Received by Manufacturer: 12/18/2025; 12/30/2025
• Initial Report FDA Received Date: 12/08/2025
• Supplement Report FDA Received Date: 12/30/2025; 12/30/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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
• Concomitant Medical Products and Therapy/Usage Dates: 277KB (UNIPOLAR HIGH FREQUENCY CORD, 300 CM).
• Patient Sex: Unknown