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Catalog Number 26-1222 |
Device Problem
Failure to Auto Stop (2938)
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Patient Problem
Tissue Damage (2104)
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Event Date 01/07/2019 |
Event Type
Injury
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Manufacturer Narrative
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(b)(4).It has been reported that the device will be returned for evaluation.Upon receipt of the device or additional relevant information, a follow-up report will be submitted.
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Event Description
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As reported, a perforator was utilized in a surgery for left temporal-sphenoidal brain tumor and failed to disengage.The patient was undergoing surgery for left temporo-sphenoidal brain tumour.During the surgery, the drill of trephine (trepan) did not disconnect¿.Clinical consequences ¿laceration of the dura matter and simple surgery follow up¿.
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Manufacturer Narrative
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Udi: (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 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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It was stated in error that there was no lot number provided, however, udi number and information was filled out correctly.The narrative should state: 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.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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Search Alerts/Recalls
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