COVIDIEN, FORMERLY USSC PUERTO RICO INC SPACEMAKER BLUNT TIP TROCAR 10MM; LAPAROSCOPE, GENERAL & PLASTIC SURGERY
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Model Number OMST10BT |
Device Problems
Air Leak (1008); Material Integrity Problem (2978)
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Patient Problem
No Known Impact Or Consequence To Patient (2692)
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Event Date 01/09/2017 |
Event Type
malfunction
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Manufacturer Narrative
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(b)(4).(b)(6).
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Event Description
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According to the reporter, during a laparoscopic cholecystectomy procedure, after using the camera port the surgeon found that there was some damage "at the value of a trocar." as a result, there was air leakage.There was patient involvement, but no patient injury.
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Manufacturer Narrative
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Post market vigilance (pmv) led an evaluation of one device.The event report alleges the product was used in a surgical procedure.The visual inspection of the returned product noted; the obturator, balloon, lock collar and valve doors appeared intact.There was visible damaged to the valve seal.The inflation syringe was received.Pmv performed functional testing; the balloon was inflated, no leaks detected.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; therefore, a device history record will not be performed.Replication of the damaged valve seal 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.No relationship between the device and the reported incident was confirmed.Should new information become available, the file will be re-opened and the investigation summary will be amended as appropriate.If information is provided in the future, a supplemental report will be issued.
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Search Alerts/Recalls
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