Catalog Number 261221 |
Device Problem
Failure to Auto Stop (2938)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 03/10/2021 |
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 physician reported disengagement failure of a perforator during surgery.It occurred during the first burr hole, the physician made a total of three burr holes.It is unknown if there was patient injury or surgical delay.
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Manufacturer Narrative
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The perforator (261221) was returned for evaluation: failure analysis - the perforator unit was inspected using the unaided eye.Unit was lightly soiled from surgery and had partially worn label that could not be read.No other anomalies were observed.Ifu testing was performed per procedure with no observed anomalies.Functional testing was performed using the same protocol it underwent at finished goods testing prior to release.The unit was found to perform as intended and fulfilled the acceptance criteria.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 - product was received for analysis and the investigation could not confirm the complaint.The root cause is undetermined and was unable to be confirmed in the complaint evaluation.A trending and risk assessment were performed as part of the evaluation.The risk remains acceptable per the risk analysis.
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Search Alerts/Recalls
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