MAUDE Adverse Event Report: KARL STORZ SE & CO. KG CUTTING LOOP, BIPOLAR, 24/26 FR.

Model Number	27040GP1-S
Medical Device Problem Codes	Break (1069); Detachment of Device or Device Component (2907)
Health Effect - Clinical Codes	Foreign Body In Patient (2687); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/11/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device will be forwarded to the manufacturing site for investigation.Should relevant additional information / investigation results become available, a supplemental medwatch report will be submitted unsolicited.This event is filed under internal complaint (b)(4).
Event or Problem Description
It was reported during a turp procedure on (b)(6) 2024, the cutting loop, bipolar, 24/26 fr broke off inside the patient.However, the doctor was able to retrieve the broken loop end.No harm to the patient was noted and no surgical delay was reported.
Additional Manufacturer Narrative
Per investigation by the manufacturing site: according to the customer's description, broke off inside the patient.The reason for this could be, that the tensile force on the loop was too high without the hf current being activated.Another possibility is that the activation time was too long and the wire burned through as a result.The ifu points out the correct handling.Since the broken wire was not sent back to karl storz tuttlingen, it is not possible to determine how often it was used and whether it is worn out.Therefore, a more detailed examination cannot be carried out.Based on the given facts we assume an application error.This event is filed under internal complaint id (b)(4).

• Brand Name: CUTTING LOOP, BIPOLAR, 24/26 FR.
• Common Device Name: CUTTING LOOP, BIPOLAR
• Manufacturer (Section D): KARL STORZ SE & CO. KG; dr.-karl-storz-strasse 34; tuttlingen 78532 ; GM 78532
• Manufacturer (Section G): KARL STORZ SE & CO. KG; dr.-karl-storz-strasse 34; tuttlingen 78532 ; GM 78532
• Manufacturer Contact: anja fair ; 2151 e grand ave; el segundo, CA 90245 ; 4242188247
• MDR Report Key: 19924047
• Report Number: 9610617-2024-00245
• Device Sequence Number: 8094835
• Product Code: FAS
• UDI-Device Identifier: 04048551393482
• UDI-Public: 04048551393482
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• 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: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 11/08/2024

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: 27040GP1-S
• Device Catalogue Number: 27040GP1-S
• Device Lot Number: 37LB4594
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/11/2024
• Supplement Date Received by Manufacturer: 11/04/2024
• Initial Report FDA Received Date: 08/06/2024
• Supplement Report FDA Received Date: 11/08/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown