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

Model Number	27050E
Medical Device Problem Code	Thermal Decomposition of Device (1071)
Health Effect - Clinical Code	Dysuria (2684)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The affected device has been requested for investigation by the manufacturer.The device was not yet returned for investigation.Cross reference complaint id: - (b)(4) - (b)(4) the event is filed under internal karl storz complaint id: (b)(4).
Event or Problem Description
It was reported that "2 loops are getting broken within 10 minutes of surgery.The user observed a burn mark on the white part of the working element and requested inspection to evaluate whether it could be related to the reported post-operative dysuria.The patient was kept on urine alkalizer & pain medication, and no hospitalization was extended due to this issue." cross reference mdr: 9610617-2026-01179 9610617-2026-01180.

• Brand Name: WORKING ELEMENT
• Common Device Name: WORKING ELEMENT
• Manufacturer (Section D): KARL STORZ SE & CO. KG; dr.-karl-storz-strasse 34; tuttlingen 78532
• MDR Report Key: 25262705
• Report Number: 2020550-2026-01178
• Device Sequence Number: 13398018
• Product Code: FDC
• UDI-Device Identifier: 04048551077542
• UDI-Public: 04048551077542
• Combination Product (Y/N): N
• Initial Reporter Country: IN
• 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): 05/22/2026
• Report Date (Section F): 05/22/2026

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: 27050E
• Device Catalogue Number: 27050E
• Device Lot Number: WL13
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 05/06/2026
• Event Location: Hospital
• Date Report to Manufacturer: 05/22/2026
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 05/22/2026
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention; Other
• Patient Sex: Unknown