MAUDE Adverse Event Report: KARL STORZ ENDOVISION VIDEO-URETERO-RENOSCOPE FLEX XC

Model Number 11278VSUEK

Device Problem Retraction Problem (1536)

Patient Problem Rupture (2208)

Event Date 02/23/2024

Event Type  Injury  

Manufacturer Narrative

The device will be forwarded to the manufacturing site for investigation.Should relevant additional information / investigation results become available, a supplemental medwatch report will be submitted unsolicited.This event is filed under internal case # (b)(4).

Event Description

It was reported that, during a pcnl with ureteroscopy on (b)(6) 2024, the ureteroscope got stuck mid-ureter.Scope was removed with ureter stuck near the distal end.Ureteral damage was reported, and a reconstruction of the ureter was required.Ureter was placed back in preparation for repair.Customer confirmed that the patient is doing ok now.The ureter was reconstructed and patient is making good progress.No nephrecotomy needed.

• Brand Name: VIDEO-URETERO-RENOSCOPE FLEX XC
• Type of Device: VIDEO-URETERO-RENOSCOPE
• Manufacturer (Section D): KARL STORZ ENDOVISION; 91 carpenter hill road; charlton MA 01507
• MDR Report Key: 18882553
• MDR Text Key: 337412700
• Report Number: 2020550-2023-00057
• Device Sequence Number: 1
• Product Code: FGB
• UDI-Device Identifier: 04048551417003
• UDI-Public: 4048551417003
• Combination Product (y/n): N
• Reporter Country Code: US
• 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: 03/11/2024

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
• Device Operator: Health Professional
• Device Model Number: 11278VSUEK
• Device Catalogue Number: 11278VSUEK
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 02/23/2024
• Event Location: Hospital
• Date Report to Manufacturer: 03/11/2024
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 03/11/2024
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Required Intervention
• Patient Age: 67 YR
• Patient Sex: Male
• Patient Weight: 56 KG