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

Model Number	11278VU
Health Effect - Clinical Code	Laceration(s) (1946)
Date of Event	06/13/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
No evaluation has been conducted by karl storz as the hospital has not released the subject ureteroscope for evaluation.
Event or Problem Description
Allegedly, during a stone removal procedure with a flex-xc video ureteroscope, the patient's ureter was torn.

• Brand Name: FLEX-XC VIDEO URETEROSCOPE
• Common Device Name: VIDEO URETEROSCOPE
• Manufacturer (Section D): KARL STORZ ENDOVISION; 91 carpenter hill road; charlton MA 01507
• MDR Report Key: 7708326
• Report Number: 1221826-2018-00057
• Device Sequence Number: 2580345
• Product Code: FGB
• UDI-Device Identifier: 04048551278239
• UDI-Public: 4048551278239
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: K131369
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,user f
• Initial Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date (Section B): 06/21/2018

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?: No
• Operator of Device: Health Professional
• Device Model Number: 11278VU
• Device Catalogue Number: 11278VU
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/09/2018
• Initial Report FDA Received Date: 07/20/2018
• 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
• Patient Age: 74 YR
• Patient Weight: 136