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 Codes	Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/15/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Customer will not return the device to us, and thus cannot 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 (b)(4).
Event or Problem Description
It was reported that during a hysteroscopic polypectomy or myomectomy procedure on (b)(6) 2024, the bipolar cutting loop broke inside of the patient.The yellow piece was retrieved, however the metal tip was not recovered and was presumed left inside the patient.No patient injury was reported.Patient is home and doing well.The next step is being decided.
Additional Manufacturer Narrative
Correction made in section d4, with the correct udi number.Per investigation by the manufacturing site: device was not returned, therefore no examination can be carried out.Based on past complaints with a similar fault description, it can be assumed that the material of the cutting loop has become thinner due to wear and could therefore break under load.It must therefore be assumed that this was an user error.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: 19299392
• Report Number: 9610617-2024-00132
• Device Sequence Number: 12226242
• Product Code: FAS
• Combination Product (Y/N): N
• 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
• 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: 04/15/2024
• Supplement Date Received by Manufacturer: 08/28/2024; 09/04/2026
• Initial Report FDA Received Date: 05/13/2024
• Supplement Report FDA Received Date: 09/22/2024; 10/01/2026
• 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: Unknown