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Model Number AORTIC CUTTERS, 5-PACK (3.8MM) |
Device Problem
Premature Activation (1484)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 09/15/2021 |
Event Type
malfunction
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Manufacturer Narrative
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Trackwise id #(b)(4).Since the device is not available to be returned to us, a technical evaluation cannot be performed.Per our standard sop's, all events are tracked and trended to determine whether or not any trends develop.
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Event Description
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The hospital reported that during a coronary artery bypass procedure, using aortic cutters (3.8mm).After releasing the safety lock of ac-3038, it could not be used because it was activated by just touching the activation button lightly.There was no effect on the patient because he was wearing the cap.The surgery was successfully completed using the new ac-3038.
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Manufacturer Narrative
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Trackwise # (b)(4).Updated section: g4, g7, h2, h6, h10.Analysis of production for ncmr, reworks, or deviations: (3331/213/67) the device history records review concluded that there were no ncmrs, rework, or deviations documented for the reported lot number.Based on the dhr/lhr review results, it was determined that there is no relation between the batch manufacturing process and the reported failure.Historical data analysis: (4109/213/67) the review of the historical data indicates that no other similar complaints was reported for the same serial number and reported failure mode.Trend analysis: (4110/213/67) the overall 24 month product complaint trend data for the period oct 2019 through sept 2021 was reviewed.There were no triggers identified for the review period.
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Event Description
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N/a.
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Search Alerts/Recalls
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