Model Number A1059 |
Device Problem
Unstable (1667)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 03/01/2022 |
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 during "craniotomy for left frontal lesion" procedure, the two-pin side on the mayfield modified skull clamp (a1059) was rocking after being pinned and locked to the patient.No patient injury or surgical delay has been reported.
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Event Description
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N/a.
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Manufacturer Narrative
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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 investigation of the returned device showed that the reported complaint was confirmed from the evaluation.Unit is older than 7 years, recommend for unit to be replaced.The estimated life expectancy for mayfield products is 7 years in consideration of all the variables that can influence the life and function of these devices.As this item is not repairable, this is returning unrepaired and is not safe for clinical use.Root cause - complaint confirmed via inspection of the unit.Service and repair found that the index knob and rocker arm failed the functional check.Due to the age of the unit the probable root cause is routine use and age related wear or lack or preventive maintenance.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.
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Search Alerts/Recalls
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