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

Model Number	011160-10
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/13/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that bipolar loop broke during use outside of the patient's body.The broken piece is deemed too small to x-ray and check cystoscopy was clear.According to the doctor, it is highly unlikely that the tiny loop would be in the patient and there is no clinical harm.Patient will have check cystoscopy in a few weeks as follow up.
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).

• Brand Name: ELECTRODE, BIPOLAR
• Common Device Name: ELECTRODE, BIPOLAR
• Manufacturer (Section D): KARL STORZ SE & CO. KG; dr.-karl-storz-strasse 34; tuttlingen 78532
• MDR Report Key: 22063336
• Report Number: 2020550-2025-00899
• Device Sequence Number: 18052069
• Product Code: FAS
• UDI-Device Identifier: 04048438005408
• UDI-Public: 04048438005408
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• 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): 05/21/2025
• Report Date (Section F): 05/21/2025

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
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 05/06/2025
• Event Location: Hospital
• Date Report to Manufacturer: 05/21/2025
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 05/21/2025
• 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: Other
• Patient Sex: Unknown
• Date Report Sent to FDA: 05/21/2025