Evaluation summary: post market vigilance (pmv) led an evaluation of one device.A visual inspection of the returned product noted: that the trocar balloon was cut.The locking collar, valve seal, valve doors and obturator appeared intact.The inflation syringe was received.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 cut balloon may occur when mishandled 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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