Catalog Number 261221 |
Device Problem
Fail-Safe Did Not Operate (4046)
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Patient Problem
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)
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Event Type
malfunction
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Event Description
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A facility reported a perforator failed to disengage.No additional information has been provided after several attempts.
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Manufacturer Narrative
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An investigation has been initiated based on the reported information.Upon completion of the investigation, a follow-up report will be submitted.
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Manufacturer Narrative
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The perforator was received for evaluation: dhr - there is no indication that the production process may have contributed to this complaint.All test results passed procedural specifications.Failure analysis - the perforator unit was inspected using the unaided eye.Unit was lightly soiled and had a green tinted eo label.Ifu testing was performed with no observed anomalies.Functional testing was performed using the same protocol it underwent at finished goods testing prior to release: the unit was found to perform as intended and fulfilled the acceptance criteria.The complaint could not be verified through failure analysis.The root cause is undetermined and was unable to be confirmed in the complaint evaluation.
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Event Description
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N/a.
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Search Alerts/Recalls
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