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

Model Number	27050E
Medical Device Problem Code	Sparking (2595)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/17/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
It is unknown if the affected device will be returned for investigation 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).This event is filed under internal complaint id: (b)(4).
Event or Problem Description
It was reported that the urologist was resecting while using 27050e, 277kb and a valley lab esu.While resecting, he noticed a spark where the 277kb connects to the 27050e.This was a one time spark.No patient was harmed.No hospital staff was harmed".No negative impact in state of health reported.Cross reference medwatach 9610617-2025-00783.
Additional Manufacturer Narrative
Correction to section d7a updated to no.Cross reference complaint id: (b)(4).This event is filed under internal 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, 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: 21961252
• Report Number: 9610617-2025-00782
• Device Sequence Number: 13060941
• Product Code: FDC
• UDI-Device Identifier: 04048551077542
• UDI-Public: 04048551077542
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• 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: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 05/13/2025

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: 27050E
• Device Catalogue Number: 27050E
• Device Lot Number: OS02
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/18/2025
• Supplement Date Received by Manufacturer: 05/12/2025
• Initial Report FDA Received Date: 05/05/2025
• Supplement Report FDA Received Date: 05/14/2025
• 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
• Patient Sex: Unknown