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

Model Number 11278VU

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Laceration(s) (1946)

Event Date 06/13/2018

Event Type  Injury  

Manufacturer Narrative

No evaluation has been conducted by karl storz as the hospital has not released the subject ureteroscope for evaluation.

Event 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
• Type of Device: VIDEO URETEROSCOPE
• 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 e. grand avenue; el segundo, CA 90245-5017 ; 4242188201
• MDR Report Key: 7708326
• MDR Text Key: 114669645
• Report Number: 1221826-2018-00057
• Device Sequence Number: 1
• Product Code: FGB
• UDI-Device Identifier: 04048551278239
• UDI-Public: 4048551278239
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K131369
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,user f
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 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
• Device Operator: Health Professional
• Device Model Number: 11278VU
• Device Catalogue Number: 11278VU
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 07/09/2018
• Initial Date FDA Received: 07/20/2018
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 04/12/2018
• 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
• Patient Age: 74 YR
• Patient Weight: 136