MAUDE Adverse Event Report: KARL STORZ SE & CO. KG CUTTING LOOP, BIPOLAR, 27/28 FR.

Model Number	27040GPB1-S
Medical Device Problem Codes	Unexpected Therapeutic Results (1631); Material Twisted/Bent (2981); Output Problem (3005)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/11/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported the petal was used it was not cutting or stopping the bleeding.The loop bent due to no cutting and pushing against the tissue there was no delayed in the case.No harm to patient.There was no glow at all on the cutting loop.Cross reference complaint id (b)(4).
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 id (b)(4).
Additional Manufacturer Narrative
Correction has been made to section h6 medical device problem code (a).This event is filed under internal complaint id (b)(4).
Additional Manufacturer Narrative
Per investigation by the manufacturing site: the investigation has clearly shown that the deformation of the items is not due to a production fault.The primary cause is related to transport conditions, where improper handling and insufficient protection during transit led to the damage.The device history records have been checked and found to be according to the specification, valid at the time of production.This event is filed under internal complaint id (b)(4).

• Brand Name: CUTTING LOOP, BIPOLAR, 27/28 FR.
• Common Device Name: CUTTING LOOP, BIPOLAR, 27/28 FR.
• 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
• MDR Report Key: 21944056
• Report Number: 9610617-2025-00730
• Device Sequence Number: 18281333
• Product Code: FAS
• UDI-Device Identifier: 04048551393529
• UDI-Public: 04048551393529
• Combination Product (Y/N): N
• Initial Reporter State: MD
• 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,Followup
• Report Date (Section B): 12/17/2025

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: 27040GPB1-S
• Device Catalogue Number: 27040GPB1-S
• Device Lot Number: 37JD5355
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/21/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/11/2025
• Supplement Date Received by Manufacturer: 05/07/2025; 11/25/2025
• Initial Report FDA Received Date: 05/01/2025
• Supplement Report FDA Received Date: 05/08/2025; 12/17/2025
• 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
• Concomitant Medical Products and Therapy/Usage Dates: 27040GPB1-S CUTTING LOOP, BIPOLAR, 27/28 FR.
• Patient Sex: Unknown