Catalog Number 26-1221 |
Device Problem
Dull, Blunt (2407)
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Patient Problem
No Known Impact Or Consequence To Patient (2692)
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Event Date 03/01/2018 |
Event Type
malfunction
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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 completion of the investigation, a follow-up report will be submitted.
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Event Description
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It was reported that it could not be perforated in properly when the surgeon drilled.The product was replaced with another one.It was unknown if the product is defective.There was no adverse consequence to the patient and no further information was provided by hospital reported.The product will be returned.
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Manufacturer Narrative
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The perforator was returned for evaluation.The device was visually inspected and minor tearing was found on the product label.No other anomalies observed.Functional testing was then performed.A series of five holes was drilled without issue.A review of manufacturing records found no anomalies when the device was released to stock.Based on the results of 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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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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A review of manufacturing records found no anomalies.Upon completion of the evaluation of the device, a follow-up report will be submitted.
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Search Alerts/Recalls
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