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

Model Number	27040GP140-S
Medical Device Problem Codes	Break (1069); Material Fragmentation (1261)
Health Effect - Clinical Codes	Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the bipolar cutting loop broke during procedure.No additional information was provided.
Additional Manufacturer Narrative
Attempts were made to obtain additional information and to have device returned for evaluation; however, there has been no response from the reporter.Once the evaluation is completed or if new information is received, a supplemental report would be made to the fda.This complaint will be tracked and trended.The event is filed under internal karl storz complaint id: (b)(4).
Additional Manufacturer Narrative
Changes made from the initial report: ---updated the udi number in section d4.Per investigation by the manufacturing site: according to the customer's description, it can be assumed that the cutting loop was pulled out in the distal area.The reason for this could be, for example, that the tensile force on the loop was too high without the hf current being activated or, on the other hand, that the activation time was too long and the wire burned out as a result.The ifu points out the correct handling.However, based on complaints in the past, it can be assumed that the user caused the fault.This event is filed under internal complaint id (b)(4).

• Brand Name: CUTTING LOOP, BIPOLAR, 24/26 FR.
• Common Device Name: CUTTING LOOP, BIPOLAR, 24/26 FR.
• 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
• MDR Report Key: 18916442
• Report Number: 9610617-2024-00070
• Device Sequence Number: 6769884
• Product Code: FAS
• UDI-Device Identifier: 04048551393208
• UDI-Public: 04048551393208
• Combination Product (Y/N): N
• Initial Reporter State: TX
• 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: User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 08/26/2024

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: 27040GP140-S
• Device Catalogue Number: 27040GP140-S
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/19/2024
• Supplement Date Received by Manufacturer: 08/12/2024
• Initial Report FDA Received Date: 03/15/2024
• Supplement Report FDA Received Date: 08/26/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Is the Device Labeled for Single Use? (Y/N): No
• 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