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

Model Number	26160SHW
Medical Device Problem Codes	Crack (1135); Material Fragmentation (1261)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/12/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The affected device has been requested for investigation by the manufacturer.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 fragment was identified in the uterus when viewed on the monitor during the cervical procedure with the 26160shw(zp02).The procedure was delayed to identify and remove the debris; however, the debris was very fine and could not be removed.There has been no impact on the patient so far.

• Brand Name: SCISSORS, 5 FR.
• Common Device Name: SCISSORS, 5 FR.
• Manufacturer (Section D): KARL STORZ SE & CO. KG; dr.-karl-storz-strasse 34; tuttlingen, 78532 ; GM 78532
• MDR Report Key: 17326739
• Report Number: 2020550-2023-00159
• Device Sequence Number: 15044457
• Product Code: GCJ
• UDI-Device Identifier: 04048551094655
• UDI-Public: 4048551094655
• Combination Product (Y/N): N
• Initial Reporter Country: KS
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Importer
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 07/14/2023
• Report Date (Section F): 07/13/2023

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: 26160SHW
• Device Catalogue Number: 26160SHW
• Device Lot Number: ZP02
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 07/13/2023
• Event Location: Hospital
• Date Report to Manufacturer: 07/13/2023
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 07/14/2023
• 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