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

Model Number	011160-10
Medical Device Problem Codes	Break (1069); Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/22/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The affected device has been requested for investigation by the manufacturer.Should relevant additional information / investigation results become available, a supplemental medwatch report will be submitted unsolicited.This event is filed under internal complaint id (b)(4).
Event or Problem Description
It was reported on (b)(6) 2025 during a turp procedure, a piece of the loop broke inside the patient.Broke piece was removed.There was no injury to the patient.No negative impact in state of health reported.
Additional Manufacturer Narrative
Correcting h-5 as this is a single use product.This event is filed under internal complaint id (b)(4).
Additional Manufacturer Narrative
Per investigation by the manufacturing site: the cutting loop is broken off and missing.The remaining rod from the cutting loop is bent towards the neutral electrode - as well as the neutral electrode is bent lateral.As the remaining electrode is bent in itself, it is most likely that the electrode got exposed to excessive force during application.This event is filed under internal complaint id (b)(4).
Additional Manufacturer Narrative
Correction is provided in section g2.This event is filed under internal complaint id (b)(4).

• Brand Name: ELECTRODE,BIPOLAR,CUTTING LOOP
• Common Device Name: ELECTRODE,BIPOLAR,CUTTING LOOP
• Manufacturer (Section D): KARL STORZ SE & CO. KG; dr.-karl-storz-strasse 34; tuttlingen, deu 78532 ,; GM 78532,
• Manufacturer (Section G): KARL STORZ SE & CO. KG; dr.-karl-storz-strasse 34; tuttlingen, deu 78532 ,; GM 78532,
• Manufacturer Contact: anja fair ; 2151 e. grand avenue; el segundo, CA 90245 ; 4242188247
• MDR Report Key: 21333259
• Report Number: 9610617-2025-00129
• Device Sequence Number: 15485889
• Product Code: FAS
• UDI-Device Identifier: 04048438005408
• UDI-Public: 04048438005408
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K221893
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 05/08/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• 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: 854217
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/03/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: 03/24/2025; 03/20/2025; 05/07/2025
• Initial Report FDA Received Date: 02/07/2025
• Supplement Report FDA Received Date: 03/25/2025; 03/31/2025; 05/08/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Sex: Unknown