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

Model Number	26040GP1-S
Medical Device Problem Codes	Break (1069); Material Fragmentation (1261)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/23/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported during a turbt procedure on (b)(6) 2024, the end of the electrode fell into the patient's bladder, the doctor was able to flush the electrode out.The procedure completed with a new sterile single use bipolar cutting loop.No injuries were reported and no surgical delays.
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
The device in question was returned to the manufacturer.This information is reflected in section d9.The evaluation is anticipated, but not yet begun.The investigation will be performed by a designated karl storz employee.This event is filed under internal complaint id (b)(4).
Additional Manufacturer Narrative
Per investigation by the manufacturing site: the loop is broken/scorched in the upper area.This happens when the loop wire gets too hot.In combination with excessive force, this can lead to breakage.The heat build-up can also damage the internal components, causing the broken part to detach from the linkage.The instructions for use recommend checking the cutting loop for damage before each use.It must be assumed that the user is at fault.This event is filed under internal complaint id (b)(4).

• Brand Name: 24/26FR BIPOLAR CUTTING LOOP
• Common Device Name: Electrode, Electrosurgical, Active, Urological
• 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: 19985902
• Report Number: 9610617-2024-00247
• Device Sequence Number: 7163858
• Product Code: FAS
• Combination Product (Y/N): N
• Initial Reporter State: PA
• 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,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: 37HC5975
• 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: 07/23/2024
• Supplement Date Received by Manufacturer: 09/23/2024; 11/18/2024; 09/04/2026
• Initial Report FDA Received Date: 08/14/2024
• Supplement Report FDA Received Date: 10/23/2024; 12/04/2024; 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 Age: 78 YR
• Patient Sex: Male
• Patient Weight: 182 LB