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

Model Number	27040D
Medical Device Problem Code	Excessive Heating (4030)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Serious Injury
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 both the resectoscope and the cable overheated during the procedure, giving off a burnt smell.As the hospital did not have a replacement device available, they borrowed one from another hospital.Consequently, the operation was paused for 45 minutes.The procedure was successfully completed using the replacement device.No negative impact in state of health reported.Since the procedure was prolonged for 45 minutes, the case is deemed as reportable.

• 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
• MDR Report Key: 22896091
• Report Number: 2020550-2025-01471
• Device Sequence Number: 20330259
• Product Code: HIH
• UDI-Device Identifier: 04048551075470
• UDI-Public: 04048551075470
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Importer
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 08/26/2025
• Report Date (Section F): 08/26/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 27040D
• Device Catalogue Number: 27040D
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 08/11/2025
• Event Location: Hospital
• Date Report to Manufacturer: 08/26/2025
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 08/26/2025
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: ARTICLE: 279 CORD,HI FREQUENCY. CURVED.
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown