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 01/09/2024 |
Event Type
malfunction
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Manufacturer Narrative
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(b)(4).Medwatch (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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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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Qn#(b)(4).Customer complaint is confirmed since the unit had the tip stuck and could not be disengaged manually.The core was measured and met the specification.The blade could not be measured since it was required use tooling and force to release the core causing a damage in the internal diameter of blade.Therefore, any dimension taken will not be reliable.However, all punch are 100% tested during manufacturing process to confirm verifying that it slides softly without getting stuck per work instruction.A device history record review was performed, and no relevant findings were identified.Even though the unit was stuck there is not sufficient evidence to assure this is a manufacturing defect and it is unknown if instructions and warnings per ifu were properly followed.No dimensional issues were found in the core, therefore it cannot be confirmed as a manufacturing defect.Complaints of this type will continue to be monitored via periodic reviews to evaluate if any trend exists.Other remarks: n/a.Corrected data: n/a.
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Search Alerts/Recalls
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