Catalog Number 261221 |
Device Problem
Activation Problem (4042)
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Patient Problem
No Known Impact Or Consequence To Patient (2692)
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Event Date 05/25/2020 |
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 premature disengagement of the perforator in the middle of a burr hole.The procedure was completed with a replacement product.No patient injury reported, it is unknown if the event led to surgical delay.
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Manufacturer Narrative
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Unique device identifier (udi): (b)(4).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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Manufacturer Narrative
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Unique device identifier (udi): (b)(4).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.No anomalies were observed, the unit had organic matter.Ifu testing was performed 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 root cause is undetermined and was unable to be confirmed in the complaint evaluation.
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Event Description
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N/a.
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Search Alerts/Recalls
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