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

Model Number	26159EHW
Medical Device Problem Codes	Crack (1135); Material Fragmentation (1261)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/10/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
Tiny metal fragments (powder-like) were dislodged from the scissors when it was inserted into the patient's uterus via single-flow operating sheath.One larger fragment attempted to be removed but washed out when trying to transfer to the specimen container.
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).

• Brand Name: SCISSORS, BLUNT, 5 FR., 34 CM
• Common Device Name: SCISSORS, BLUNT
• Manufacturer (Section D): KARL STORZ SE & CO. KG; dr.-karl-storz-strasse 34; tuttlingen, 78532 ; GM 78532
• MDR Report Key: 17491414
• Report Number: 2020550-2023-00206
• Device Sequence Number: 20646346
• Product Code: GCJ
• UDI-Device Identifier: 04048551094280
• UDI-Public: 4048551094280
• Combination Product (Y/N): N
• Initial Reporter Country: HK
• 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): 08/09/2023
• Report Date (Section F): 08/09/2023

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: 26159EHW
• Device Catalogue Number: 26159EHW
• Device Lot Number: VR01
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 08/09/2023
• Event Location: Hospital
• Date Report to Manufacturer: 08/09/2023
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 08/09/2023
• 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