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

Model Number 11278VSUAK

Device Problem Device Damaged by Another Device (2915)

Patient Problems Rupture (2208); Injury (2348)

Event Date 11/09/2018

Event Type  Injury  

Manufacturer Narrative

Our evaluation found that the angle cover along the vertebrae was split and the vertebrae was broken near the split area.There were multiple cuts and long gouges on both sides of the angle cover which most likely caused the angle cover to split.The split measures approximately 10 - 11 mm long.A broken rivet was found due to excessive force.

Event Description

Per medwatch report, mw5081358, received on 12/6/18.It stated pt for left ureteral cystoscopy with laser lithotripsy for large symptomatic kidney stone.After stone fragmentation, the scope was withdrawn and revealed the left ureter had been avulsed and the distal end of the ureter was entrapped in the exposed metal vertebrae at the distal end of the scope.The patient was taken for an urgent nephrostomy tube placement.The patient was admitted for stabilization and observation.The patient was discharged to home with foley and nephrostomy with plan for reconstructive procedure in the future.

• Brand Name: VIDEO-URETERO-RENOSCOPE FLEX XC
• Type of Device: FLEX XC
• Manufacturer (Section D): KARL STORZ ENDOVISION; 91 carpenter hill road; charlton MA 01507
• Manufacturer (Section G): KARL STORZ ENDOVISION; 91 carpenter hill road; charlton MA 01507
• Manufacturer Contact: susie chen ; 2151 east grand avenue; el segundo, CA 90245-5017 ; 4242188201
• MDR Report Key: 8152315
• MDR Text Key: 129961937
• Report Number: 1221826-2018-00093
• Device Sequence Number: 1
• Product Code: FGB
• UDI-Device Identifier: 04048551402603
• UDI-Public: 4048551402603
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K141250
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 11/12/2018

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: 11278VSUAK
• Device Catalogue Number: 11278VSUAK
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/28/2018
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 11/12/2018
• Initial Date FDA Received: 12/11/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/11/2018
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Required Intervention
• Patient Age: 34 YR