MAUDE Adverse Event Report: KARL STORZ SE & CO. KG SPARE LOOP FOR SUPRALOOP, 200 X 150 MM

Model Number	26183MD
Medical Device Problem Code	Lack of Effect (4065)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/10/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The affected device has been requested for investigation by the manufacturer.Device was not returned at the time of mdr submission.The event is filed under internal karl storz complaint id: (b)(4).
Event or Problem Description
According to the information received, poor cutting function, cutting function was questionable, current function was questionable.Cervix was severed primarily by pulling on the loop.The procedure was not completed successfully.Additional information, cutting function was questionable, current function was questionable.Cervix was severed primarily by pulling on the loop.Hf setting: lash program.Max 130 watts, softcut - smooth cutting.Procedure was not completed successfully with less than 15 mins delay.

• Brand Name: SPARE LOOP FOR SUPRALOOP, 200 X 150 MM
• Common Device Name: SPARE LOOP FOR SUPRALOOP, 200 X 150 MM
• Manufacturer (Section D): KARL STORZ SE & CO. KG; dr.-karl-storz-strasse 34; tuttlingen, 78532 ; GM 78532
• MDR Report Key: 23659220
• Report Number: 2020550-2025-02172
• Device Sequence Number: 10123634
• Product Code: KNF
• UDI-Device Identifier: 04048551393567
• UDI-Public: 04048551393567
• Combination Product (Y/N): N
• Initial Reporter Country: SZ
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Importer
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 11/26/2025
• Report Date (Section F): 11/26/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 26183MD
• Device Catalogue Number: 26183MD
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 11/10/2025
• Event Location: Hospital
• Date Report to Manufacturer: 11/26/2025
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 11/26/2025
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown