MAUDE Adverse Event Report: KARL STORZ SE & Co. KG Electrode, bipolar

Model Number	011050-10
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/02/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that three resection loops fractured during the procedure.An additional sterile resection set was opened to retrieve the broken fragment.The device malfunction resulted in a prolonged procedure and prolonged general anesthesia.
Additional Manufacturer Narrative
The affected device has been requested by the manufacturer but has not yet returned for evaluation.The investigation will be performed by a designated karl storz employee.The event is filed under internal karl storz complaint id: (b)(4).Cross reference internal complaint id: (b)(4).

• Brand Name: Electrode, bipolar
• Common Device Name: Electrode, bipolar
• Manufacturer (Section D): KARL STORZ SE & Co. KG; dr.-karl-storz-strasse 34; tuttlingen 78532 ; GM 78532
• MDR Report Key: 50212547
• Report Number: 50212547
• Device Sequence Number: 6098028
• Product Code: FAS
• UDI-Device Identifier: 04048551412633
• UDI-Public: 04048551412633
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• 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): 08/11/2026
• Report Date (Section F): 08/11/2026

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: 011050-10
• Device Catalogue Number: 011050-10
• Device Lot Number: 859194
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 08/03/2026
• Event Location: Hospital
• Date Report to Manufacturer: 08/11/2026
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 08/11/2026
• 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: Material: 011050-10Batch/Lot Code: 859194; Material: 011050-10Batch/Lot Code: 859194
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown