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Catalog Number 26-1221 |
Device Problem
Dull, Blunt (2407)
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Patient Problem
No Consequences Or Impact To Patient (2199)
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Event Date 01/21/2019 |
Event Type
malfunction
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Manufacturer Narrative
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(b)(4).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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Event Description
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It was reported that perforator was dull to open the hole.The surgery was completed by using another one.There was no surgical delay and there was no adverse consequence to the patient.No further information was provided by hospital.The product will be returned to your site.
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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 it was slightly soiled and the label was worn.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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