CODMAN MODULAR AIR DRIVER
Received Dec 28, 2012 · Event occurred Nov 7, 2012
Report 1226348-2012-84134 · MDR key 2889124
Device
Product problems
- Sticking
- Device Operates Differently Than Expected
Patient
Not reported
- No Known Impact Or Consequence To Patient
Narrative
Description of Event or Problem
THE AFFILIATE REPORTED THAT THE SECURE DO NOT ALLOW THE ACTIVATION OF THE EQUIPMENT AND THE TREPHONE PIECE GOT STUCK. AFFILIATE REPORTED DALAY IN SURGERY AS A RESULT OF THIS INCIDENT.
Additional Manufacturer Narrative
UPON COMPLETION OF THE INVESTIGATION IT WAS NOTED THAT THE VENDOR'S EVALUATION REVEALED THAT INSTRUMENTS WERE CORRODED, MISSING COMPONENTS, AND WORN. THE CONDITION OF THESE INSTRUMENTS IS ASSOCIATED WITH EXCESSIVE USE OVER A LONG PERIOD OF TIME. INSTRUMENTS ARE OLD AND ARE OUT OF WARRANTY. BASED ON THE RESULTS OF THIS INVESTIGATION NO FURTHER ACTION IS REQUIRED. TRENDS WILL BE MONITORED FOR THIS AND SIMILAR COMPLAINTS. AT THE PRESENT TIME THIS COMPLAINT IS CLOSED.
Additional Manufacturer Narrative
UPON COMPLETION OF THE INVESTIGATION A FOLLOW UP REPORT WILL BE FILED.