Catalog Number 544995 |
Device Problems
Activation, Positioning or Separation Problem (2906); Difficult to Open or Close (2921)
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Patient Problem
No Consequences Or Impact To Patient (2199)
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Event Date 04/28/2016 |
Event Type
malfunction
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Manufacturer Narrative
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(b)(4).The device has not been returned for investigation at this time.The manufacturer will continue to monitor and trend related events.
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Event Description
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The clips were staying in the applier after application to the vessel and clips fell into the patient which was retrieved.The patient's condition was reported as fine.
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Manufacturer Narrative
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(b)(4).The dhr for the instrument in question, was reviewed and found completely without any irregularities.This instrument was manufactured at the tecomet , inc.(b)(4) facility as part of a 50pc.Lot in march of 2016.Since the instrument was not returned for evaluation, we are unable to validate this complaint or determine root cause.All instruments are thoroughly inspected and function tested at time of manufacture.No corrective action required at this time.
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Event Description
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The clips were staying in the applier after application to the vessel and clips fell into the patient which was retrieved.The patient's condition was reported as fine.
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Manufacturer Narrative
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(b)(4).The dhr for the instrument in question, was reviewed and found complete without any irregularities.This instrument was manufactured at the tecomet, inc.(b)(4) facility as part of a 50pc.Lot in march of 2016.The returned instrument was evaluated and found that the jaws are aligned properly and both the closed and open jaw dimensions measured to print specs.And that this instrument picks up, retains, closes and releases clips both with and without the use of silastic test tubing as required of its function.Parts were 100% visually inspected and tested at the tecomet, inc.(b)(4) facility before instruments were sent to customer.No irregularities were found and or reported at the time of inspection and assembly of the product, as this is a standardized process for all instruments manufactured at this facility.We are unable to validate the alleged complaint since we were unable to replicate the alleged condition.No corrective action required at this time.Conclusion - no conclusion code available that could accurately describe that the complaint was confirmed, but the root cause is unknown.
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Event Description
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The clips were staying in the applier after application to the vessel and clips fell into the patient which was retrieved.The patient's condition was reported as fine.
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Search Alerts/Recalls
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