Model Number CTF33 |
Device Problem
Material Fragmentation (1261)
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Patient Problem
No Consequences Or Impact To Patient (2199)
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Event Date 01/23/2019 |
Event Type
malfunction
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Manufacturer Narrative
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The event unit is not returning to applied medical for evaluation.A follow-up report will be sent upon completion of investigation.
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Event Description
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Procedure performed: laparoscopy.Event description: please note this event occurred at the [] hospital which falls under the [] banner.At the end of the laparoscopic procedure dr [] was removing the above port from the patient.The white top portion came off and then the green side part of the port that holds the white part in place, snapped off and went down the port.The green plastic shaft of the port was still insitu in the patients abdomen.It was retrieved with an artery forcep.Patient status: no adverse effect to patient.
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Manufacturer Narrative
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The event unit was not returned to applied medical for evaluation.However, a photo of the event unit was provided by the complainant.Visual inspection confirmed the complainant's experience of a fractured cannula wing tab.In the absence of the event unit, it is difficult to determine the exact root cause of the event.Applied medical will continue to monitor its vigilance system for trends and take appropriate actions, as necessary, to ensure the performance and safety of its products.
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Event Description
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Procedure performed: laparoscopy.Event description: please note this event occurred at the [] hospital which falls under the [] banner.At the end of the laparoscopic procedure dr [] was removing the above port from the patient.The white top portion came off and then the green side part of the port that holds the white part in place, snapped off and went down the port.The green plastic shaft of the port was still insitu in the patients abdomen.It was retrieved with an artery forcep.Patient status: no adverse effect to patient.
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Search Alerts/Recalls
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