FLEXO SALIVA EJECTORS
Received Feb 21, 2023 · Event occurred Dec 20, 2023
Report 2523320-2023-00002 · MDR key 16413760
Device
Product problems
- Mechanical Problem
- Mechanical Problem
Patient
Unknown
- No Clinical Signs, Symptoms or Conditions
- No Clinical Signs, Symptoms or Conditions
Narrative
Additional Manufacturer Narrative
NO HARM TO THE PATIENT WAS NOTED. A REVIEW OF THE COMPLAINT HISTORY LOG, SHOWS NO OTHER SIMILAR COMPLAINT IN THE LAST 10 YEARS. KEYSTONE ALSO REACHED OUT TO THE MANUFACTURING SITE. THEIR INVESTIGATIONS SHOWS NO EVIDENCE OF ISSUES WITH THE PRODUCT LOT. THEY DID NOT FIND ANY OTHER CASE LIKE THIS IN THIER COMPLAINT RECORDS.
Description of Event or Problem
FLEXO SALIVA EJECTORS ARE FITTED WITH A WHITE TIP. THE TIP DETACHED FROM THE SALIVA EJECTOR TUBE DURING A COLONOSCOPY PROCEDURE. IT WAS REPORTED THAT THE PATIENT WAS SEDATED FOR A COLONSCOPY AND STARTED TO COUGH, SO HER MOUTH WAS GENTLY SUCTIONED WITH THE FLEXO SALIVA EJECTOR AND THE TIP FELL OFF INSIDE THE PATIENT'S MOUTH. THE END USER WAS ABLE TO RETRIEVE THE PLASTIC TIP FROM INSIDE THE PATIENT'S MOUTH BEFORE SHE SWALLOWED OR ASPIRATED IT. THE PATIENT DID NOT BITE THE TIP NOR DID THE USER SUCTION AGRESSIVELY.
Remedial action
- Other