Catalog Number A1059 |
Device Problem
Mechanical Problem (1384)
|
Patient Problem
No Known Impact Or Consequence To Patient (2692)
|
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
|
This is 1 of 2 reports linked to mfg report number 3004608878-2021-00055.A facility reported that the swivel lock on the mayfield skull clamp (a1059) shows no resistance and is very easy to unlock.It is unknown if there was patient involvement or if the device failure led to patient injury or surgical delay.
|
|
Manufacturer Narrative
|
The mayfield skull clamp was returned for evaluation.The reported complaint was confirmed via inspection of the unit.The lock had movement and required replacement of worn internal parts.No further investigation required based on the acceptability of risk and no adverse trends identified.This will be monitored and trended going forward.
|
|
Event Description
|
N/a.
|
|
Search Alerts/Recalls
|