MAUDE Adverse Event Report: KARL STORZ SE & CO. KG SCISSORS, 5 FR., 40 CM

Model Number	26160EHW
Medical Device Problem Code	Material Fragmentation (1261)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/22/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
This incident was deemed as an "adverse event".However we failed to file the importer medwatch, and therefore will submit the importer medwatch now retrospectively.This event is filed under internal complaint id (b)(4).
Event or Problem Description
It was reported that, during a hysteroscopy, a portion of the tip dislodged during the procedure.No patient injury was reported.Surgeon was able to remove the broken piece and was able to complete the procedure.Per customer, the case date was either on (b)(6) 2023.

• Brand Name: SCISSORS, 5 FR., 40 CM
• Common Device Name: SCISSORS
• Manufacturer (Section D): KARL STORZ SE & CO. KG; dr.-karl-storz-strasse 34; tuttlingen 78532 ; GM 78532
• MDR Report Key: 19785817
• Report Number: 2020550-2023-00171
• Device Sequence Number: 8269283
• Product Code: GCJ
• UDI-Device Identifier: 04048551094556
• UDI-Public: 4048551094556
• Combination Product (Y/N): N
• Initial Reporter State: CT
• Initial Reporter Country: US
• 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): 07/19/2024
• Report Date (Section F): 07/20/2023

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: 26160EHW
• Device Catalogue Number: 26160EHW
• Device Lot Number: VQ01
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/16/2023
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 06/23/2023
• Event Location: Hospital
• Date Report to Manufacturer: 07/20/2023
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 07/19/2024
• 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: Female