Catalog Number DP-40K |
Device Problem
Physical Resistance/Sticking (4012)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 01/19/2024 |
Event Type
malfunction
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Manufacturer Narrative
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(b)(4).Customer complaint cannot be confirmed based only on the information provided.To perform an evaluation and determine the source of defect reported it is necessary to analyze the sample involved on this complaint.A device history record review was performed, and no relevant findings were identified.An attempt to duplicate the failure mode was made but at the time there is no inventory of the involved product code available at the facility neither is being manufactured at the time.If defective sample becomes available at a later date this complaint will be updated as applicable.
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Event Description
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It was reported that the disposable aortic punch got stuck.As a result, a new device was used to complete the procedure.No patient harm or injury.
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Manufacturer Narrative
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(b)(4).Customer complaint cannot be confirmed , the unit had the tip release (no stuck) and no functional issues were observed during functional tests.A device history record review was performed, and no relevant findings were identified.However, complaints of this type will continue to be monitored via periodic reviews to evaluate if any trend exists.Teleflex will continue to monitor and trend on complaints of this nature.
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Event Description
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It was reported that the disposable aortic punch got stuck.As a result, a new device was used to complete the procedure.No patient harm or injury.
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Search Alerts/Recalls
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