MAUDE Adverse Event Report: KARL STORZ SE & CO. KG SCISSORS, POINTED, 5 FR., 34 CM

Model Number	26159SHW
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	08/15/2025
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.This importer report was accidently omitted on the day the initial report was submitted to the fda.We apologize for the delay of the importer report.We will take measures to address this delay with the specialist and the entire team to provide retraining to avoid late submissions.The event is filed under internal karl storz complaint id: (b)(4).
Event or Problem Description
According to the information received, the patient was scheduled for hysteroscopic surgery (hsk).However, the procedure proved to be difficult as it could not be performed with the bipolar resectoscope.It was therefore necessary to use hsk scissors.We had two of these instruments in our inventory, and the surgeon needed the second hsk scissors for another procedure on the same day.The hsk scissors used initially worked perfectly, but one of the scissor arms suddenly came loose during the procedure.Despite an intensive search, the broken part could no longer be found, either in the irrigation system, on the floor or elsewhere.To be on the safe side, the patient was x-rayed and no foreign body was found.As a result, the procedure was discontinued.The original findings were still present and, as things stand, the patient is to be operated on again at the campus at a later date.Due to the fact that the procedure was aborted, the original findings are still present and the patient is to be operated on again at a later date, the case is classified as reportable.Additional information was provided that the surgury was postponed until (b)(6) 2025.

• Brand Name: SCISSORS, POINTED, 5 FR., 34 CM
• Common Device Name: SCISSORS, POINTED, 5 FR., 34 CM
• Manufacturer (Section D): KARL STORZ SE & CO. KG; dr.-karl-storz-strasse 34; tuttlingen, 78532 ; GM 78532
• MDR Report Key: 22983349
• Report Number: 2020550-2025-01388
• Device Sequence Number: 9256836
• Product Code: GCJ
• UDI-Device Identifier: 04048551094471
• UDI-Public: 04048551094471
• 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): 09/05/2025
• Report Date (Section F): 08/19/2025

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: 26159SHW
• Device Catalogue Number: 26159SHW
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/14/2025
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 07/28/2025
• Event Location: Hospital
• Date Report to Manufacturer: 09/05/2025
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 09/05/2025
• 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
• Date Report Sent to FDA: 08/19/2025