MAUDE Adverse Event Report: KARL STORZ SE & CO. KG ELECTRODE, BIPOLAR

Model Number	011050-10
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
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
The following was reported: during an operative hysteroscopy, a 5 mm resection loop ref.(b)(4) (lot no.858491, exp 30.11.2029) broke during the procedure.The surgeon performed a verification endoscopically, digitally, and visually, but the loop was not found.Due to the fact that fragments or broken parts may have been left behind in the patient, this case is deemed reportable.

• 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: 24599378
• Report Number: 2020550-2026-00562
• Device Sequence Number: 9507060
• 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
• 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): 03/13/2026
• Report Date (Section F): 03/13/2026

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: 858491
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 02/27/2026
• Event Location: Hospital
• Date Report to Manufacturer: 03/13/2026
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 03/13/2026
• 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
• Patient Sex: Unknown