CODMAN & SHURTLEFF, INC. CODMAN DISPOSABLE PERFORATOR 9MM; DRILLS, BURRS, TREPHINES & ACC.
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Catalog Number 26-1223 |
Device Problem
Failure to Auto Stop (2938)
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Patient Problems
Tissue Damage (2104); Brain Injury (2219)
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Event Date 03/26/2018 |
Event Type
Injury
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Manufacturer Narrative
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(b)(4).Attempts are being made for additional information.Upon completion of the investigation, a follow-up report will be submitted.
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Event Description
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As reported by the affiliate, a perforator failed to disengage and a dural tear resulted.The patient was admitted for purulent meningitis, brain abscess and ventriculitis (probable cause of death).It was reported that the patient died after the event.There is no reported relationship between the perforator and the event of death.The device will be returned.
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Manufacturer Narrative
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Corrected fields: device available for evaluation.It was initially reported that the device would be returned for evaluation.However, multiple attempts to obtain the sample were unsuccessful.This report has been updated to reflect the corrected information.Complaint sample was not returned to codman; therefore, an evaluation of the device could not be performed.A review of manufacturing records found no discrepancies when the device was released to stock.The cause(s) of the difficulty reported by the customer could not be determined.If the complaint sample becomes available, 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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Manufacturer Narrative
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The device has been returned for evaluation.Upon completion of the investigation, a follow-up report will be submitted.
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Manufacturer Narrative
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The device was received for evaluation.The perforator was visually inspected and no anomalies were observed.The perforator was then functionally tested.A series of holes with drilled without issues.The device performed as intended.A review of manufacturing records found no discrepancies when released to stock.Based on the investigation, the reported issue could not be confirmed.The device functioned as intended.Trends will be monitored for this and similar issues.At present, we consider this complaint to be closed.
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