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

Model Number	011168-10
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	03/23/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
During a prostate resection using the thulep technique and the specific bipolar resection loop, the loop broke inside the patient when the surgeon attempted to retrieve a prostate chip.The surgeon then had to recover the small broken fragment using a single use flexible foreign body forceps.
Additional Manufacturer Narrative
The device in question was returned to the manufacturer.The evaluation is anticipated but not yet begun.The investigation will be performed by a designated karl storz employee.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 ; GM 78532
• MDR Report Key: 24984435
• Report Number: 2020550-2026-00845
• Device Sequence Number: 21202446
• 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): 04/15/2026
• Report Date (Section F): 04/24/2026

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: 011168-10
• Device Catalogue Number: 011168-10
• Device Lot Number: 858053
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/09/2026
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 03/25/2026
• Event Location: Hospital
• Date Report to Manufacturer: 04/24/2026
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 04/24/2026
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Sex: Unknown