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

Model Number 26050CA

Device Problem Material Separation (1562)

Patient Problem Insufficient Information (4580)

Event Date 07/25/2023

Event Type  Injury  

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 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
• Type of Device: 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
• MDR Text Key: 322522493
• Report Number: 2020550-2023-00229
• Device Sequence Number: 1
• Product Code: HIH
• UDI-Device Identifier: 04048551007228
• UDI-Public: 4048551007228
• Combination Product (y/n): N
• Reporter Country Code: FR
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Distributor
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 09/01/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/01/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: 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
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention