Catalog Number 511100250060 |
Device Problem
Incomplete or Inadequate Connection (4037)
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Patient Problem
No Consequences Or Impact To Patient (2199)
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Event Date 09/14/2019 |
Event Type
malfunction
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Manufacturer Narrative
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Should additional relevant information become available, a supplemental report will be submitted.
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Event Description
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It was reported that a 2.5mm coupler malfunctioned.The malfunction was further described as the "ring failed to close when pushing of the u-port".This was identified during an unspecified treatment during patient use.There was no patient injury or medical intervention associated with this event.No additional information is available.
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Manufacturer Narrative
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Additional information: the entire coupler assembly (coupler rings were intact within the jaw assembly which was contained within the white holder) was returned.The rings showed signs of use (dried blood).There were no pin marks on the rings near the mating holes which would have been an indication of ring misalignment.The coupler assembly was placed in an anastomotic instrument to mimic use within a surgical process.The knob of the anastomotic instrument was then turned to approximate the coupler rings.The rings aligned and the pins met with their mating holes as intended by the coupler design.There was no sign of misalignment observed during evaluation.The reported condition was not verified.A batch review was conducted and there were no deviations found related to this reported condition during the manufacture of this lot.Should additional relevant information become available, a supplemental report will be submitted.
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Search Alerts/Recalls
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