Catalog Number 261221 |
Device Problem
Activation, Positioning or Separation Problem (2906)
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Patient Problem
No Known Impact Or Consequence To Patient (2692)
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Event Date 07/25/2020 |
Event Type
malfunction
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Manufacturer Narrative
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Attempts are being made to obtain additional 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 the perforator failed to disengage during the 2nd burr hole.No patient injury was reported as the physician was able to pull up the device quickly.The procedure was completed using the same device.Device was used with the midas/medtronic drill drive.No surgical delay was reported.
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Manufacturer Narrative
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Unique device identifier-(b)(4).Device history record (dhr)- there is no indication that the production process may have contributed to this complaint.Failure analysis- the perforator unit was inspected using the unaided eye: organic matter, and a worn eto label were observed.Ifu testing procedure was performed with no observed anomalies.Functional testing: the unit was found to perform as intended and fulfilled the acceptance criteria.The complaint could not be verified through failure analysis.The root cause is undetermined and was unable to be confirmed in the complaint evaluation.
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Manufacturer Narrative
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Udi (b)(4).The perforator was not returned for evaluation; therefore, an evaluation of the device could not be performed.Lot number information has been provided; therefore, manufacturing records were reviewed and found no anomalies.The cause(s) of the difficulty reported by the customer could not be determined.If additional relevant information becomes available in the future, this complaint will be reopened, and the respective evaluation performed.Trends will be monitored for this and similar issues.At present, we consider this complaint to be closed.
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Event Description
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N/a.
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Search Alerts/Recalls
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