MAUDE Adverse Event Report: KARL STORZ SE & Co. KG Working Element

Model Number	27050D
Medical Device Problem Code	Excessive Heating (4030)
Health Effect - Clinical Code	Burn(s) (1757)
Date of Event	07/21/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
The following was reported: "the hospital unfortunately had an incident in theatre where a patient sustained a thermal injury from a resection scope.The team and surgeon report that the burn looked like it came from around the area where the cable plugs in to the scope.On closer inspection they noticed a small area where the metal has blackened which may indicate a leak from the loop filament rather than the instrument.".
Additional Manufacturer Narrative
The affected device has been requested for investigation by the manufacturer.The device was not yet returned for investigation.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
• MDR Report Key: 50310110
• Report Number: 50310110
• Device Sequence Number: 8770184
• Product Code: FDC
• UDI-Device Identifier: 04048551077474
• UDI-Public: 04048551077474
• Combination Product (Y/N): N
• Initial Reporter Country: NZ
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 08/18/2026
• Report Date (Section F): 08/18/2026

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: 27050D
• Device Catalogue Number: 27050D
• Device Lot Number: OY06
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 07/25/2026
• Event Location: Hospital
• Date Report to Manufacturer: 08/18/2026
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 08/18/2026
• 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: 011110-01 Batch: 860933; Article: 277KB Batch: SM01
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown