MAUDE Adverse Event Report: KARL STORZ SE & CO. KG 24/26FR BIPOLAR CUTTING LOOP BOX 6 UNITS; Electrode, Electrosurgical, Active, Urological

Model Number	26040GP1-S
Medical Device Problem Code	Material Fragmentation (1261)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/04/2024
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 id (b)(4).
Event or Problem Description
It was reported that during a bladder tumor removal procedure on (b)(6) 2024, the cutting loop broke off.They were able to complete the procedure without any patient injury, and were also able to retrieve the broken piece.
Additional Manufacturer Narrative
Changes made from the initial report: updated the udi number in section d4.Per investigation by the manufacturing site: as can be seen in the attached pictures, the cutting loop is broken.The diameter of the wire at the point of breakage indicates that it has been in use for a longer period of time.Due to wear and the thinning diameter, the loop can break quickly as a fold.The melting on the insulation also shows that it has become very warm, which may be due to the fact that it was not operated in batches, for example.The ifu advises customer to check the cutting loop for damage before each use.This event is filed under internal complaint id (b)(4).

• Brand Name: 24/26FR BIPOLAR CUTTING LOOP BOX 6 UNITS
• Common Device Name: Electrode, Electrosurgical, Active, Urological
• 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: 19629241
• Report Number: 9610617-2024-00188
• Device Sequence Number: 18341324
• Product Code: FAS
• Combination Product (Y/N): N
• Initial Reporter State: MO
• Initial Reporter Country: US
• PMA/510(K) Number: K221893
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• 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): 09/30/2026

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: 26040GP1-S
• Device Catalogue Number: 26040GP1-S
• Device Lot Number: 37HC5459
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/07/2024
• Supplement Date Received by Manufacturer: 08/22/2024; 09/04/2026
• Initial Report FDA Received Date: 06/27/2024
• Supplement Report FDA Received Date: 09/12/2024; 10/01/2026
• 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: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown