SAUNDERS CERVICAL TRCTN DVCE
Received Nov 17, 2022 · Event occurred Oct 21, 2022
Report 9616086-2022-00031 · MDR key 15820705
Product problems
- Defective Component
- Defective Component
Patient
Unknown
- Insufficient Information
- Insufficient Information
Narrative
Additional Manufacturer Narrative
IT WAS REPORTED THAT AFTER AIR PRESSURE IS APPLIED, ONCE RELEASED, THE AIR ALLEGEDLY COMES OUT IMMEDIATELY INSTEAD OF GRADUAL RELEASE. IT WAS REPORTED THAT PATIENTS ARE ALLEGEDLY GETTING HURT FROM QUICK RELEASE. THE DEVICE WAS RETURNED TO ENOVIS FOR EVALUATION. A FUNCTIONAL TEST COULD NOT BE DONE DUE TO THE PUMP BEING DAMAGED AND THE PRODUCT WILL NOT WORK CORRECTLY, THE MALFUNCTION REPORTED BY THE CUSTOMER HAS BEEN CONFIRMED. ENOVIS HAS REACHED OUT TO THE CUSTOMER FOR ADDITIONAL INFORMATION ON PATIENTS AND HAVE NOT RECEIVED ANY TO DATE.
Description of Event or Problem
IT WAS REPORTED THAT AFTER AIR PRESSURE IS APPLIED, ONCE RELEASED, THE AIR ALLEGEDLY COMES OUT IMMEDIATELY INSTEAD OF GRADUAL RELEASE. IT WAS REPORTED THAT PATIENTS ARE ALLEGEDLY GETTING HURT FROM QUICK RELEASE.