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

Model Number	011160-10
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	07/16/2025
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 intracavitary fibroid.Transcervical resection performed.The procedure was technically challenging.A small loop electrode fractured during the operation and was identified immediately.The fragment, approximately 4 mm in size, was not visible upon inspection and is presumed to have been expelled with the irrigation fluid.The loop was replaced with a new disposable electrode to complete the procedure.A check hysteroscopy was performed at the end of the procedure, and no foreign body was identified within the endometrial cavity.Due to the additional hysteroscopy the event 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: 22785117
• Report Number: 2020550-2025-01405
• Device Sequence Number: 21343568
• Product Code: HIH
• UDI-Device Identifier: 04048438005408
• UDI-Public: 04048438005408
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• 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): 08/12/2025
• Report Date (Section F): 08/12/2025

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: 011160-10
• Device Catalogue Number: 011160-10
• Device Lot Number: 835425
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 08/01/2025
• Event Location: Hospital
• Date Report to Manufacturer: 08/12/2025
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 08/12/2025
• 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