Model Number 174025 |
Device Problems
Failure to Fire (2610); Detachment of Device or Device Component (2907)
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Patient Problem
No Consequences Or Impact To Patient (2199)
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Event Date 07/10/2019 |
Event Type
malfunction
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Manufacturer Narrative
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If information is provided in the future, a supplemental report will be issued.
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Event Description
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According to the reporter, during laparoscopic partial fundoplication, the device did not fire properly.In addition, the lower clamp cover fell into patient's cavity and was retrieved.A new device was used to complete the case.There was no patient injury.
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Manufacturer Narrative
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Evaluation summary: post market vigilance (pmv) led an evaluation of one device.The e-piece was disengaged from the device.The single use loading unit (sulu) was received preloaded on the instrument with seven tacks remaining.The sulu was unloaded from the instrument.The handle was actuated and cycled properly.Records from each manufacturing lot are thoroughly reviewed to ensure that products are released meeting all quality release specifications at the time of manufacture.Replication of the reported condition may occur as a result of excessive manipulation of the device.The root cause of the observed damage was due to the product not being used as intended which caused or contributed to the reported condition.No further actions have been deemed necessary at this time.If information is provided in the future, a supplemental report will be issued.
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Event Description
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According to the reporter, during laparoscopic partial fundoplication, the device did not fire properly.In addition, the lower clamp cover fell into patient's cavity and was retrieved with the used of forceps.A new device was used to complete the case.There was no patient injury.
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Search Alerts/Recalls
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