According to the reporter during a laparoscopic inguinal hernia repair, at the beginning of the procedure, when inserting the laparoscopic device, for the first trocar the valve seal, the reducer part of the trocar was damaged and the balloon sphere was deflated and was also damaged during surgery, the second device had it's valve seal, reducer damaged during use.Another device was used to complete the case.There was no patient injury.
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Evaluation summary: post market vigilance (pmv) led an evaluation of one device.The visual inspection of the returned product noted: the circular seal for the trocar balloon was cut and disengaged.The inflation syringe was not received.The insufflation bulb was received.The lock collar, trocar balloon and dissector balloon appeared intact.A functional evaluation found that the trocar balloon was inflated using a test syringe, no leaks detected.The dissector balloon could not be inflated due to the disengaged seal.A review of the device history record indicates this product was released meeting all quality release specifications at the time of manufacture.Replication of cut in the circular seal may occur when contact is made with a sharp surgical instrument during clinical application.The root cause of the observed damage was due to the product not being used as indicated 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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