inforMED
MalfunctionJYK

SPECULUM HOLDER FOR MCO980 LEGENT [MXI/XOM]

Received Aug 26, 2013 · Event occurred Jul 29, 2009

Report 9680837-2013-00048 · MDR key 3306977

Device

Generic name

Holder, Ear Speculum

Model number

MCO981

Catalog number

MCO981

Lot number

0209

Product problems

  • Break

Patient

Not reported

  • No Known Impact Or Consequence To Patient

Narrative

Description of Event or Problem

THE DEVICE (SPECULUM HOLDER MCO981 FOR MCO980 LEGENT) WAS RETURNED TO MXI FOR SERVICE AND REPAIR. IT WAS REPORTED THAT THE SPRING DOES NOT WORK. THERE WAS NO REPORTED PATIENT IMPACT.

Additional Manufacturer Narrative

(B)(4). ANALYSIS OF THE DEVICE (SPECULUM HOLDER MCO981 FOR MCO980 LEGENT) INDICATED THAT ONE OF THE SPRING LEVERS HAD BROKEN OFF AT THE BASE. 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.