Catalog Number 261221 |
Device Problem
Mechanical Problem (1384)
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Patient Problem
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)
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Event Date 02/16/2021 |
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 a perforator underwent initial check with midas rex drill prior to use in the patient and the surgical staff reported the perforator ¿felt gritty and not freely moving so they did not want to use it.¿ it was used with a pneumatic drill, it was confirmed the perforator clicked into place in the drill and the recommended spring tests were performed.Another perforator was opened and used without difficulty.
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Manufacturer Narrative
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The perforator was returned for evaluation.Device history: record (dhr) there is no indication that the production process may have contributed to this complaint.All test results passed procedural specifications.Failure analysis: the perforator unit was inspected using the unaided eye.The unit was lightly soiled, no anomalies were observed.The returned unit was found to work as intended, and met all acceptance criteria.The complaint could not be verified through failure analysis.Root cause: the root cause is undetermined and was unable to be confirmed in the complaint evaluation.The risk remains acceptable per the risk analysis.
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Search Alerts/Recalls
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