Catalog Number A1059 |
Device Problem
Mechanical Problem (1384)
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Patient Problem
No Known Impact Or Consequence To Patient (2692)
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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 knob on the mayfield skull clamp (a1059) locks and unlocks with no resistance.It is unknown if there was patient involvement or if the device failure led to patient injury or surgical delay.
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Manufacturer Narrative
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Unique device identifier: (b)(4).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 via inspection of the unit.The lock was not holding, unit needed new components added to replace 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.
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Event Description
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N/a.
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Search Alerts/Recalls
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