DEPUY MITEK LLC US 4580 FMS DUO+ PUMP/SHAVER COMBO -NS; DISTENSION UNIT, FLUID, ARTHROSCOPIC
|
Back to Search Results |
|
Catalog Number 284580 |
Device Problem
Suction Failure (4039)
|
Patient Problem
No Consequences Or Impact To Patient (2199)
|
Event Date 01/04/2016 |
Event Type
malfunction
|
Manufacturer Narrative
|
If additional information should become available, a supplemental medwatch will be submitted accordingly.(b)(4).The date device returned to manufacturer was unknown.Evaluation statement: tips and rubber feet were worn out.Top case damaged, sub'd connector broken, chamber holder and guide line twisted.This report is being filed from the (b)(4) as required under mitek's corrective and preventative actions (capa) to file usa fda mdr missed malfunctions.
|
|
Event Description
|
It was reported by the customer in (b)(6) that the suction part on the 4580 fms duo+ pump/shaver combo was damaged.According to the reporter, the rotation parts did rotate but not properly and a loud noise occurred while using the pump.It was not reported if the device was used in surgery, or if there was patient involvement.It was not reported if there were any delays in a surgical procedure or if a spare device was available.It was not reported if there were any injuries, medical intervention or prolonged hospitalization.All available information has been disclosed.If additional information should become available, a supplemental medwatch report will be submitted accordingly.
|
|
Manufacturer Narrative
|
Product complaint #: (b)(4).
|
|
Search Alerts/Recalls
|
|
|