RUSCH MRI COND FIBER OPTIC LARYN KIT
Received Jul 1, 2015 · Event occurred Jun 18, 2014
Report 1044475-2015-00215 · MDR key 4883781
Device
Product problems
- Inadequate Lighting
- Optical Problem
Patient
Not reported
- No Consequences Or Impact To Patient
Narrative
Additional Manufacturer Narrative
(B)(4). THE MRI KIT WAS RETURNED FOR EVALUATION. A VISUAL EXAM WAS PERFORMED AND IT WAS OBSERVED THAT THE MAC 2 BLADE WAS MISSING. THE COMPLAINT WAS REPORTED AS THE MAC 2 BLADE WOULD NOT ENERGIZE WHEN ENGAGED ON THE HANDLE. THE MAC 2 BLADE WAS NOT PRESENT IN THE KIT; HOWEVER, DURING FUNCTIONAL TESTING OF ALL OF THE RETURNED BLADES, IT WAS FOUND THAT TWO OF THE BLADES WOULD NOT ENERGIZE: THE MAC 3, AND THE MIL 1. THE SMALL INCANDESCENT BULBS WHICH ARE SEATED IN THE FOCS LIGHT BUNDLE WERE EITHER DEFECTIVE OR BURNED OUT. BASED ON THE INVESTIGATION PERFORMED, THE REPORTED COMPLAINT WAS CONFIRMED. IT SHOULD BE NOTED THAT THE BLADE THAT WAS REPORTED DEFECTIVE WAS NOT RETURNED, BUT THERE WERE DEFECTIVE BLADES IN THE KIT. THE ROOT CAUSE AS TO WHY THE BULBS BURNED OUT COULD NOT BE DETERMINED. A CONCLUSION CODE COULD NOT BE FOUND AS THE COMPLAINT WAS CONFIRMED, HOWEVER, A ROOT CAUSE WAS NOT ESTABLISHED.
Description of Event or Problem
THE CUSTOMER ALLEGES THAT THE LIGHT BUNDLE WILL NOT LIGHT ON THE MAC 2 BLADE. INTUBATION WAS ACCOMPLISHED WITH A STANDARD LARYNGOSCOPE SET. NO PATIENT INJURY REPORTED.
Description of Event or Problem
THE CUSTOMER ALLEGES THAT THE LIGHT BUNDLE WILL NOT LIGHT ON THE MAC 2 BLADE. INTUBATION WAS ACCOMPLISHED WITH A STANDARD LARYNGOSCOPE SET. NO PATIENT INJURY REPORTED.
Additional Manufacturer Narrative
(B)(4). THE DEVICE SAMPLE WAS NOT RETURNED FOR EVALUATION AT THE TIME OF THIS REPORT.