Catalog Number A1059 |
Device Problems
Loose or Intermittent Connection (1371); Unstable (1667)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Type
malfunction
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Manufacturer Narrative
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An investigation has been initiated based on the reported information.Upon completion of the investigation, a follow-up report will be submitted.
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Event Description
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A facility reported that the locking mechanism on the mayfield modified skull clamp (a1059) was loose and unstable.It is unknown if there was patient involvement; however, no patient injury or surgical delay has been reported.
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Manufacturer Narrative
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Device history record: the dhr shows no abnormalities related to the reported failure.Mayfield modified skull clamp (a1059) was returned for evaluation.The reported complaint was confirmed.Evaluation showed that the lock has rotational and lateral movement and a residue buildup is present.The unit needs repair, and replacement of worn parts.General maintenance and cleaning required.No further investigation required based on the acceptability of risk and no adverse trends identified.This will be monitored and trended going forward.
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Event Description
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N/a.
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Search Alerts/Recalls
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