Catalog Number MDP-36K |
Device Problems
Sticking (1597); Mechanical Jam (2983)
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Patient Problem
No Consequences Or Impact To Patient (2199)
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Event Date 02/12/2018 |
Event Type
malfunction
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Manufacturer Narrative
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(b)(4).The device history review could not be conducted since the lot number was not provided.The device has not been returned at this time.Teleflex will continue to monitor and trend related events.
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Event Description
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It was reported that the current aortic punch used, the operation was not smooth, and after punching it got stuck and had difficulty disengaging.On punching the aorta, the device did not release there was difficulty in dispensing the punch.The device was removed, was not replaced, another attempt was made, treatment was not delayed, no complications or injury.
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Manufacturer Narrative
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(b)(4).The device history record of batch number provided has been reviewed and no issues or discrepancies were found which could potentially relate to this complaint.No corrective actions can be implemented due the lack of product sample to perform a proper investigation and determine the root cause.Customer complaint cannot be confirmed due the lack of product sample to perform a proper investigation and determine the root cause.
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Event Description
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It was reported that the current aortic punch used, the operation was not smooth, and after punching it got stuck and had difficulty disengaging.On punching the aorta, the device did not release there was difficulty in dispensing the punch.The device was removed, was not replaced, another attempt was made, treatment was not delayed, no complications or injury.
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Manufacturer Narrative
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(b)(4) sample was received without its original package instead the sample was sent on a sterilized bag with a protective cap at the core.Note: at first sight, no signs of use were detected to the sample.Sample was received without its original package instead the sample was sent on a sterilized bag with a protective cap at the core.Note: at first sight, no signs of use were detected to the sample.A portion of clean pork aorta was used in order to review the functionality of the sample.Five (5) cuts/punches were performed, no problem was found with the functionality of the aortic punch.Sample was analyzed in accordance to current specifications and manufacturing controls with no functional issues found.Based on the analysis of the sample received, customer complaint is not confirmed.However, manufacturing personnel was notified of this event for awareness.
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Event Description
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It was reported that the current aortic punch used, the operation was not smooth, and after punching it got stuck and had difficulty disengaging.On punching the aorta, the device did not release there was difficulty in dispensing the punch.The device was removed, was not replaced, another attempt was made, treatment was not delayed, no complications or injury.
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Search Alerts/Recalls
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