MAUDE Adverse Event Report: KARL STORZ SE & CO. KG 26040GP1

Model Number	26040GP1
Medical Device Problem Codes	Break (1069); Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/14/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The affected device has been requested for investigation by the manufacturer.The device was not yet returned for investigation.The event is filed under internal karl storz complaint id: (b)(4).
Event or Problem Description
It was reported that "during hysteroscopic surgery, the doctor used an electrosurgical cutting loop to separate intrauterine tissue and coagulate bleeding points.While the cutting loop was in use inside the uterine cavity, a circumferential fracture occurred at the front 1.5 cm × 1.5 cm section of the loop." according to the available information the procedure was completed successfully with a prolongation of 10 minutes and there were no adverse consequences for the patient.No negative impact in state of health reported.

• Brand Name: 26040GP1
• Common Device Name: 26040GP1
• 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
• MDR Report Key: 25115813
• Report Number: 9610617-2026-01034
• Device Sequence Number: 9326118
• Product Code: HIN
• UDI-Device Identifier: 04048551392720
• UDI-Public: 04048551392720
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K122983
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 06/23/2026

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
• Device Catalogue Number: 26040GP1
• Device Lot Number: OK17
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/22/2026
• Supplement Date Received by Manufacturer: 06/19/2026
• Initial Report FDA Received Date: 05/07/2026
• Supplement Report FDA Received Date: 06/23/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Is the Device Labeled for Single Use? (Y/N): No
• 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