Model Number 8886848882 |
Device Problem
Failure to Fire (2610)
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Patient Problem
No Known Impact Or Consequence To Patient (2692)
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Event Date 01/10/2019 |
Event Type
malfunction
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Manufacturer Narrative
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If information is provided in the future, a supplemental report will be issued.
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Event Description
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According to the reporter during a procedure, the clipping could not be performed with the cartridges.The event occurred during the procedure but the product was not used for patient.The procedure was completed with another device.There was no patient harm.
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Manufacturer Narrative
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Evaluation summary: post market vigilance (pmv) led an evaluation of one device.The visual inspection noted the cartridge was received applied with the clip body disengaged and the tracks were not inserted properly at the distal end of the clip body.Functionally; the clip body and tracks were reloaded into the cartridge and fired with acceptable results.Records from each manufacturing lot are thoroughly reviewed to ensure that products are released meeting all quality release specifications at the time of manufacture.Replication of the observed condition may occur if the clip was not properly applied and mishandled during the clinical application.The root cause of the observed damage was misuse of the product which caused or contributed to the reported condition.No further actions have been deemed necessary at this time.If information is provided in the future, a supplemental report will be issued.
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Manufacturer Narrative
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This event has been reassessed and found to be a non-mdr reportable complaint.If information is provided in the future, a supplemental report will be issued.
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Search Alerts/Recalls
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