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

Model Number	26183MD
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/23/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during intraoperative use of the supra-loop, it was discovered that the coating at the distal end of the loop was defective.The instrument (loop) was replaced intraoperatively with another identical loop.The surgery was able to continue.Distal end of the loop: coating detached no negative impact in state of health reported.
Additional Manufacturer Narrative
The device in question was returned to the manufacturer.The evaluation is anticipated but not yet begun.The investigation will be performed by a designated karl storz employee.The event is filed under internal karl storz complaint id: (b)(4).

• 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
• 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: 24886515
• Report Number: 9610617-2026-00821
• Device Sequence Number: 21288039
• Product Code: KNF
• UDI-Device Identifier: 04048551393567
• UDI-Public: 04048551393567
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K944793
• 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
• Report Date (Section B): 04/15/2026

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: 26183MD
• Device Catalogue Number: 26183MD
• Device Lot Number: NN03
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/08/2026
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/23/2026
• Initial Report FDA Received Date: 04/15/2026
• Was Device Evaluated by Manufacturer? (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