Model Number ONB12STF |
Device Problems
Gas/Air Leak (2946); Packaging Problem (3007)
|
Patient Problem
No Consequences Or Impact To Patient (2199)
|
Event Date 12/03/2018 |
Event Type
malfunction
|
Manufacturer Narrative
|
If information is provided in the future, a supplemental report will be issued.
|
|
Event Description
|
According to the reporter, during a laparoscopic gastric bypass, the trocar leaked carbon dioxide throughout the case.The seal did not function properly.The surgeon worked through the issue to complete the case.There was no patient injury.
|
|
Manufacturer Narrative
|
Evaluation summary: post market vigilance (pmv) led an evaluation of one device.The visual inspection of the returned product noted that the circular seal was stretched.The trocar and cannula appeared intact.The obturator was received.The envelope seal was stretched out.The obturator was received inserted into the cannula.Prolonged insertion can cause the envelop seal to become stretched.The stopcock was intact.Pmv performed functional testing; the device failed an air leak test.The trocar was disassembled to measure weld height, the weld height was in spec.(.250 +/-.005).Records from each manufacturing lot are thoroughly reviewed to ensure that products are released meeting all quality release specifications at the time of manufacture.Analysis concluded there were no assembly component related failures.If information is provided in the future, a supplemental report will be issued.
|
|
Search Alerts/Recalls
|