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Model Number 26-1221 |
Device Problem
Failure to Auto Stop (2938)
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Patient Problem
Tissue Damage (2104)
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Event Date 06/26/2018 |
Event Type
Injury
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Manufacturer Narrative
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It has been reported that the device will not be returned for evaluation.A lot number has been provided.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 at the dura mater, causing a cerebral contusion.The secure system leading to disengage of perforator has not been activate that leading to a cerebral contusion (without injury, hemorrhage or cerebral disintegration), no further intervention was needed.The drill bit has been removed and there was no vital risk for the patient.Microscopically, the brain has been damaged but the contusion is not found on the scan.The patient must have an mri soon.This was the first time the device was used.It was reported that the bone quality was normal and the device was help perpendicular to the bony surface during use.
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Manufacturer Narrative
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Udi (b)(4).Additional 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 anomalies.The cause(s) of the difficulty reported by the customer could not be determined.Complaint will be closed as 'no complaint sample returned to codman for evaluation'.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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Udi: (b)(4).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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Search Alerts/Recalls
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