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 Code	Mechanical Problem (1384)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/04/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
It is unknown if the affected device will be returned for investigation by the manufacturer.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 equipment broke, identified during procedure by attending while operating, noticed on camera scope bipolar cutting loop not working properly.No negative impact in state of health reported.
Additional Manufacturer Narrative
Updated section g3 adding aware date 04/01/2025.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: 21873927
• Report Number: 9610617-2025-00661
• Device Sequence Number: 8640684
• Product Code: FAS
• Combination Product (Y/N): Y
• Initial Reporter State: CA
• 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): 09/22/2026

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: 37LC1751
• Was Device Available for Evaluation?: No
• 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: Not provided
• Supplement Date Received by Manufacturer: 04/01/2025; 09/04/2026
• Initial Report FDA Received Date: 04/21/2025
• Supplement Report FDA Received Date: 04/30/2025; 09/22/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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 Sex: Female