Catalog Number 261221 |
Device Problem
Fail-Safe Did Not Operate (4046)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 07/06/2023 |
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 (id (b)(6)) during surgery.No adverse consequences for the patient.The drill used with the perforator was a midas (medtronic).According to information provided, it is unknown if the drill was electric or pneumatic, or if the perforator clicked in place on the drill.It is also unknown if the recommended spring tests were performed between each burr hole.
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Event Description
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N/a.
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Manufacturer Narrative
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The perforator (id 261221) was returned for evaluation.Device history record (dhr)- 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: unit was lightly soiled but had no other anomalies.Ifu (instructions for use) testing procedure was performed with no observed anomalies.Functional testing was performed using the same protocol it underwent at finished goods testing prior to release and the unit was found to perform as intended and fulfilled the acceptance criteria.The complaint could not be verified through failure analysis.Root cause analysis- the root cause is undetermined and was unable to be confirmed in the complaint evaluation.The potential causes of failure include: user misuse.
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Search Alerts/Recalls
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