MAUDE Adverse Event Report: KARL STORZ SE & CO. KG CUTTING LOOP, BIPOLAR, 0.30MM, 24/26 FR.

Model Number	27040GP130-S
Medical Device Problem Codes	Detachment of Device or Device Component (2907); Material Twisted/Bent (2981)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/15/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the cutting loop broke off in patient during use.No negative impact in state of health reported.
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
Procedure that was performed on the patient was blue light transurethral resection of the bladder tumor.The surgeon was able to retrieve all of the pieces.Update sections a2 and a3a.This event is filed under internal complaint id (b)(4).
Additional Manufacturer Narrative
This event is filed under internal complaint id (b)(4).
Additional Manufacturer Narrative
Per investigation by the manufacturing site: the returned product was inspected in the warehouse and compared with the customer's information; the described defect was confirmed.In item 27040gp130, batch number wl17, a break in the cutting loop was detected at the distal end.The most likely cause is assumed to be excessive mechanical stress on the cutting loop.This could have occurred if the product was used without activation (no power flow, foot switch not pressed).In this case, increased force is exerted on the cutting loop during use, which can lead to deformation, material fatigue, and ultimately breakage.It is therefore crucial to strictly follow the instructions for use and preparation to ensure safe use of the product.This event is filed under internal complaint id (b)(4).

• Brand Name: CUTTING LOOP, BIPOLAR, 0.30MM, 24/26 FR.
• Common Device Name: CUTTING LOOP, BIPOLAR, 0.30MM, 24/26 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, CA 90245 ; 4242188247
• MDR Report Key: 22593215
• Report Number: 9610617-2025-01263
• Device Sequence Number: 9052496
• Product Code: FAS
• UDI-Device Identifier: 04048551393864
• UDI-Public: 04048551393864
• 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: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 03/10/2026

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: 27040GP130-S
• Device Catalogue Number: 27040GP130-S
• Device Lot Number: 37AE0451
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/22/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/16/2025
• Supplement Date Received by Manufacturer: Not provided; 08/01/2025; 03/10/2026
• Initial Report FDA Received Date: 07/24/2025
• Supplement Report FDA Received Date: 08/05/2025; 08/14/2025; 03/10/2026
• 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 Age: 47 YR
• Patient Sex: Male