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	06/03/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during a transurethral resection of prostate procedure on (b)(6) 2024, the cutting loop broke off inside of the patient.They were able to remove the broken piece using a bladder evacuator, and were able to complete the procedure using a back-up without any patient injury.This issue caused a delay of about 10 minutes to the case.
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
Changes made from the initial report: updated the udi number in section d4.Per investigation by the manufacturing site: at the breakage points of the cutting wire, it can be seen that both tapers run up to the break.This is a sign that the material in the cutting area has been stressed by prolonged use/high stress.As a result, the material became thinner, which led to the cutting loop breaking.Based on the given facts, we assume user error to be the cause for this issue.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: 19629562
• Report Number: 9610617-2024-00189
• Device Sequence Number: 8610132
• Product Code: FAS
• Combination Product (Y/N): N
• Initial Reporter State: IL
• 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: 37JC8522
• 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: 06/03/2024
• Supplement Date Received by Manufacturer: 08/14/2024; 09/04/2026
• Initial Report FDA Received Date: 06/27/2024
• Supplement Report FDA Received Date: 08/28/2024; 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