Model Number A1059 |
Device Problem
Mechanics Altered (2984)
|
Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
|
Event Type
malfunction
|
Manufacturer Narrative
|
An investigation has been initiated based on the reported information.Upon completion of the investigation, a follow-up report will be submitted.
|
|
Event Description
|
A facility reported that the locking mechanism on mayfield modified skull clamp (a1059) was loose and unstable.No information has been provided on patient involvement, injury, or surgical delay.
|
|
Manufacturer Narrative
|
The mayfield modified skull clamp (a1059) was returned for evaluation: device history record (dhr): the dhr was reviewed and shows no abnormalities related to the reported failure.Failure analysis - the complaint is confirmed via inspection of the unit which shows that the lock has rotational and lateral movement and a residue buildup was present.New components were added to replace worn internal parts, and general maintenance and cleaning were performed.Root cause - there was movement present in the lock and the unit required replacement of worn components due to routine use and wear.No further investigation is required based on the acceptability of risk and no adverse trends were identified.This will be monitored and trended going forward.At present, we consider this complaint to be closed.
|
|
Search Alerts/Recalls
|