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Catalog Number ATS45 |
Device Problems
Failure to Advance (2524); Failure to Form Staple (2579); Failure to Cut (2587); Firing Problem (4011)
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Patient Problem
No Consequences Or Impact To Patient (2199)
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Event Date 01/12/2019 |
Event Type
malfunction
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Manufacturer Narrative
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Product complaint #: (b)(4).Batch # unk.Attempts have been made to retrieve the device.To date the device has not been returned.If the device or further details are received at a later date, a supplemental medwatch will be sent.The manufacturing record evaluation was performed, and the manufacturing criteria was met prior to the release of this batch/lot.
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Event Description
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It was reported that during a pediatric lap appendectomy, three staplers: the same thing happened with each of them.They were ats45 staplers, each time they were using a tr45w.No reloads will be returned.Each time they closed down on tissue and went to fire, partial staples would deploy and nothing would cut and nothing would advance.The tech said the devices did not lock out.They were able to remove the staplers without cutting them out.Case completed with a fourth device of the same product code.There were no patient consequences reported.
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Manufacturer Narrative
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Product complaint(b)(4).Batch # r5ax59.Investigation summary: the analysis results found that the ats45 device was returned with no apparent damage and with no reload present on the device.The device was tested for functionality with a test reload and it fired, cut and formed the staples as intended.The device fired without any difficulties, the staple line was complete, the cut line was complete and the staples were noted to have the proper b-formed shape.The event described could not be confirmed as the device performed without any difficulties noted.There may have been other circumstances or issues that occurred during the use of the device that we were unable to duplicate during our laboratory analysis.A manufacturing record evaluation was performed for the finished device batch number, and no non-conformances were identified.
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Search Alerts/Recalls
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