RUSCH MRI COND FIBER OPTIC LARYN KIT
Received Aug 19, 2015 · Event occurred Jul 29, 2015
Report 1044475-2015-00311 · MDR key 5015166
Device
Product problems
- Fitting Problem
Patient
Not reported
- No Consequences Or Impact To Patient
- No Patient Involvement
Narrative
Additional Manufacturer Narrative
(B)(4). UPON RECEIPT THE GOLD PIPE LIGHT AND BULB BASE WERE DETACHED FROM THE BLADE. NO OBVIOUS DAMAGE NOTED VISUALLY. THE GOLD PIPE LIGHT WAS RE-INSTALLED ONTO THE BLADE WITH NO FITTING OR ALIGNMENT ISSUES NOTED. THE BLADE WAS ATTACHED TO A KNOWN GOOD HANDLE AND FITTING/ALIGNMENT WAS NOT AN ISSUE. IT WAS NOTED THAT THE LIGHT WAS NOT BURNING AFTER THE BLADE WAS ENGAGED. AFTER FURTHER INVESTIGATION IT WAS DETERMINED THE SMALL INCANDESCENT BULB WAS BURNED OUT. THE ORIGINAL COMPLAINT OF THE PIPE LIGHT NOT FITTING ONTO THE BLADE CANNOT BE CONFIRMED. THE COMPLAINT CANNOT BE CONFIRMED. ROOT CAUSE CANNOT BE ESTABLISHED. NO CORRECTIVE/PREVENTATIVE ACTIONS WILL BE ASSIGNED. NO FURTHER ACTION REQUIRED.
Description of Event or Problem
THE CUSTOMER ALLEGES HAVING DIFFICULTY REASSEMBLING THE GOLD PIPE LIGHT ONTO THE BLADE. THE PATIENT'S CONDITION IS REPORTED AS FINE.