Model Number CFF73 |
Device Problems
Difficult to Insert (1316); Sticking (1597)
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Patient Problem
No Consequences Or Impact To Patient (2199)
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Event Date 05/24/2016 |
Event Type
malfunction
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Manufacturer Narrative
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Ra has received the incident device and has been assigned to engineering for evaluation.A follow-up report will be sent upon completion of investigation.In accordance to 21 cfr 803.56, if we obtain additional information, which was not known or was not available when the initial report was submitted, then the supplemental report will be submitted to the fda.
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Event Description
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Laparoscopic gastric sleeve - "when torquing the trocars instruments would become hung up in the cannula.Doctor said it feels "sticky" when moving instruments through the ports." patient status: patient is fine.
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Manufacturer Narrative
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Additional information received.Investigation summary: the event unit was returned for evaluation.Engineering visually inspected the seal and noted that the septum and shield were not concentric.Engineering attempted to replicate the customer's experience using the returned obturator, but the customer's experience could not be replicated.The septum and shield realigned to the correct position after the first insertion of the obturator.During the manufacturing process, all seals are thoroughly inspected for functionality and performance prior to packaging.The root cause of the event is likely due to instruments getting caught on the septum component of the seal during insertion /removal.Although the exact root cause could not be confirmed, 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.In accordance with 21 cfr 803.56, if additional information is obtained which was not known or was not available when this report was submitted, then a supplemental report will be submitted to the fda.
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Event Description
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Additional information received via email on june 7, 2016 from applied team member: the instruments that were being used through the ports were a 10mm camera and hunter graspers.Drag was noticed immediately once ports began being used in the early stages of the procedure.After troubleshooting with the doctor, he made the decision to remove the ports shortly after due to the drag persisting.
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Search Alerts/Recalls
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