Model Number OMS-PDB1000 |
Device Problems
Hole In Material (1293); Inflation Problem (1310)
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Patient Problem
No Known Impact Or Consequence To Patient (2692)
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Event Date 05/11/2018 |
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, the balloon was applied into the incision between the peritoneum and fascia layer on a laparoscopic inguinal hernia repair.The balloon had a hole in it and would not inflate.They opened another balloon 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) received one device.The visual inspection noted that the balloon was cut.The obturator was not received.The valve seal and doors appeared intact.The insufflation bulb was received.The condition of the device precludes functional testing.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.Replication of the cut in the balloon may occur when mishandled during clinical application.The root cause of the observed damage was misuse of the product which would have caused or contributed to the reported incident.If information is provided in the future, a supplemental report will be issued.
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Search Alerts/Recalls
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