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

Model Number	26159SHW
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/26/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that despite following the disinfection instructions, the scissors in question showed oxidation signs and rust from the first use.During the tenth use of the device in medical procedure, one of the branches of the scissors broke off inside the uterine cavity.The fragment was recovered and extracted with no adverse consequences for the patient.Procedure was completed successfully but with a prolongation of more than 30 mins.
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).
Additional Manufacturer Narrative
Additional information is provided in section d9 to reflect that the product was returned for evaluation.The investigation is not completed yet.The investigation results are pending.The event is filed under internal karl storz complaint id: (b)(4).

• 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: 21596427
• Report Number: 2020550-2025-00441
• Device Sequence Number: 8878031
• Product Code: GCJ
• UDI-Device Identifier: 04048551094471
• UDI-Public: 04048551094471
• Combination Product (Y/N): N
• Initial Reporter Country: IT
• 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,Followup
• Report Date (Section B): 06/19/2025
• Report Date (Section F): 03/13/2025

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
• Device Lot Number: VL02
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 02/26/2025
• Event Location: Other
• Date Report to Manufacturer: 03/14/2025
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 03/13/2025
• Supplement Report FDA Received Date: 06/19/2025
• 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: 03/13/2025