MAUDE Adverse Event Report: KARL STORZ SE & CO. KG ENDOSCOPE SHEATH, REUSABLE; INNER SHEATH FOR RESECTOSCOPE

Model Number	26050CA
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	07/25/2023
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 during a laser auriga 30 fragmentation of a large bladder stone with the storz resector, the ceramic tip broke off and passed into the bladder.This forced the surgeon to do a laparotomy to recover the part inside the lava.The ceramic completely separated from the sheath and passed into the bladder.The surgery was prolonged for 1h 30 minutes.The resection of the prostate was rescheduled 15 days later.

• Brand Name: ENDOSCOPE SHEATH, REUSABLE
• Common Device Name: INNER SHEATH FOR RESECTOSCOPE
• Manufacturer (Section D): KARL STORZ SE & CO. KG; dr.-karl-storz-strasse 34; tuttlingen, 78532 ; GM 78532
• MDR Report Key: 17671661
• Report Number: 2020550-2023-00229
• Device Sequence Number: 6512908
• Product Code: HIH
• UDI-Device Identifier: 04048551007228
• UDI-Public: 4048551007228
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• 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): 09/01/2023
• Report Date (Section F): 09/01/2023

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: 26050CA
• Device Catalogue Number: 26050CA
• Device Lot Number: ST01
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 09/01/2023
• Event Location: Hospital
• Date Report to Manufacturer: 09/01/2023
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 09/01/2023
• 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: Required Intervention
• Patient Sex: Unknown