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Catalog Number 261221 |
Device Problem
Insufficient Information (3190)
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Patient Problem
No Known Impact Or Consequence To Patient (2692)
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Event Date 11/03/2018 |
Event Type
malfunction
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Manufacturer Narrative
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(b)(4).Complaint sample was not returned to codman and no lot number information has been provided; therefore, an evaluation of the device could not be performed and manufacturing records could not be reviewed.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 or similar complaints.At present, we consider this complaint to be closed.
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Event Description
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As reported by the affiliate, a surgeon felt that a codman perforator was not working correctly, so he stopped using it, using a steel bar to complete the procedure.There were no reports of delay or patient harm.The unit will be returned.
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Manufacturer Narrative
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Sample was received for evaluation.The sample was visually inspected.No anomalies were observed other than that the product label was no longer present.The perforator was then functionally tested.A series of holes with drilled without issues.The device performed as intended.No lot number information has been provided; therefore, manufacturing records could not be reviewed.Based on the results of the investigation, the reported issue could not be confirmed.Trends will be monitored for this or similar complaints.
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Manufacturer Narrative
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It was previously reported that the device would not be returned for evaluation.The device was subsequently returned.Upon completion of the investigation, a follow-up report will be submitted.
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Search Alerts/Recalls
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