Evaluation summary: post market vigilance (pmv) led an evaluation of one device.The visual inspection of the returned product noted: the obturator, trocar balloon, lock collar and valve seal appeared intact.The insufflation bulb was received.The inflation syringe was not received.The dissector balloon was received.A functional evaluation found that using a test syringe the trocar balloon was inflated; no leaks were detected.The dissector balloon was inflated, a leak was detected.All other components functioned 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 hole in the dissector balloon may occur when there is contact with a sharp surgical instrument during clinical application.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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According to the reporter, during laparoscopic inguinal hernia, during dissection and inflation of the balloon, balloon can't be inflated for air started to leak out of the trocar where the scope goes into the trocar.Surgeon used a laparoscopic sponge to stop the air from leaking out near the scope.There was no patient injury.
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