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

Model Number	11278VSUAK
Medical Device Problem Code	Device Damaged by Another Device (2915)
Health Effect - Clinical Codes	Rupture (2208); Injury (2348)
Date of Event	11/09/2018
Type of Reportable Event	Serious Injury
Additional 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 or Problem 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ureteral cystoscopy with laser lithotripsy for large symptomatic kidney stone.After stone fragmentation, the scope was withdrawn and revealed the left ureter had been avulsed and the distal end of the ureter was entrapped in the exposed metal vertebrae at the distal end of the scope.The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
• Common Device Name: FLEX XC
• Manufacturer (Section D): KARL STORZ ENDOVISION; 91 carpenter hill road; charlton MA 01507
• MDR Report Key: 8152315
• Report Number: 1221826-2018-00093
• Device Sequence Number: 1552799
• Product Code: FGB
• UDI-Device Identifier: 04048551402603
• UDI-Public: 4048551402603
• Combination Product (Y/N): N
• Initial Reporter State: GA
• Initial Reporter Country: US
• PMA/510(K) Number: K141250
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: user facility
• Initial Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date (Section B): 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
• Operator of Device: 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
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/12/2018
• Initial Report FDA Received Date: 12/11/2018
• 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; Required Intervention
• Patient Age: 34 YR