INSTRUMENT MCL55 PISTOL W/NEEDLE MCL55-1 [MXI/XOM]
Received Aug 28, 2013 · Event occurred Jun 27, 2012
Report 9680837-2013-00466 · MDR key 3314899
Device
Generic name
Guide, Needle, Surgical
Manufacturer
Medtronic Xomed Instrumentation S.a.s.Model number
MCL55Catalog number
MCL55
Lot number
200004MF
Product problems
- Break
Patient
Not reported
- No Known Impact Or Consequence To Patient
Narrative
Description of Event or Problem
IT WAS REPORTED THAT AN MCL55 SLIPS UNDER PRESSURE. NO PATIENT IMPACT WAS REPORTED.
Additional Manufacturer Narrative
(B)(4). RESULTS IS MECHANICAL SHOCK PROBLEM. THE RETURNED DEVICE WAS EVALUATED AND CONFIRMED TO BE OUT OF SPECIFICATION. FUNCTIONAL TESTING WAS PERFORMED; MISSING AND DEFECTIVE COMPONENTS WERE REPLACED. NOTE: THIS MDR IS BEING FILED AS A RESULT OF AN INTERNAL REVIEW OF COMPLAINTS FROM MEDTRONIC¿S MXI FACILITY IN (B)(4). THIS REVIEW WAS CONDUCTED TO RESOLVE SEVERAL ISSUES DISCOVERED IN THE MXI COMPLAINT HANDLING PROCESS. ISSUES RESOLVED INCLUDE THE MISCLASSIFICATION OF DEVICES RETURNED FOR REPAIR, AS WELL AS GAPS IN REPORTING. MXI CAPA (B)(4) WAS OPENED TO ADDRESS THESE ISSUES.