Model Number OMS-T10SB |
Device Problem
Inflation Problem (1310)
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Patient Problem
No Consequences Or Impact To Patient (2199)
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Event Date 11/27/2019 |
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, during a laparoscopic inguinal hernia repair, three balloons from the same batch failed to inflate.Used a balloon from different batch to complete the procedure.There was no patient injury.
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Manufacturer Narrative
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Evaluation summary: post market vigilance (pmv) received three devices with the appropriate packaging.The visual inspections noted that the balloons, valve seals, lock collars and doors appeared intact.The obturators and inflation bulbs were received.A functional evaluation found that the balloons were inflated with no leaks.Records from each manufacturing lot are thoroughly reviewed to ensure that products are released meeting all quality release specifications at the time of manufacture.The investigation concluded there were no abnormalities that would have caused or contributed to the reported condition.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, during a laparoscopic inguinal hernia repair, when entering the abdomen maintaining a working space to perform the operation, sixteen balloons failed to inflate.Used a balloon from different batch to complete the procedure.There was no patient injury.
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Search Alerts/Recalls
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