Model Number CTF03 |
Device Problem
Physical Resistance (2578)
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Patient Problem
No Consequences Or Impact To Patient (2199)
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Event Date 07/18/2016 |
Event Type
malfunction
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Manufacturer Narrative
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Full udi unknown since no lot number was provided.The incident device is anticipated to return.A follow-up report will be provided 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.There is no report of serious injury or death associated with this event.
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Event Description
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Procedure performed unknown."the scrub technician (keith) indicated that dr.(b)(6) was beginning the procedure and he placed the scope into the trocar.Once he did so it would not advance all the way through and it was noticed that part of the seal was impeding the scope from going through.The surgeon then called for a new trocar and proceeded with the procedure.There was no injury to the patient." additional information received from sales representative 22 july 2016, 9:37 am: "i requested the lot # today and the customer indicated they didn't have it.".
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Manufacturer Narrative
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We have tried to obtain the incident device for evaluation with no success as of 25oct2016.The event unit was not returned for evaluation.In the absence of the subject device it is difficult to determine the root cause of the incident.A review of the manufacturing records for this lot could not be performed as no lot number was provided. during the manufacturing process, all trocars are thoroughly inspected and tested prior to packaging.Although the exact root cause of the incident could not be confirmed, applied medical will continue to monitor its vigilance system for trends and take appropriate actions as necessary.In accordance to 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 e-mail on november 17, 2016 - it was the rep's understanding that the scope was placed into the obturator that was in the cannula.Also, unfortunately i am not aware which brand of camera/ laparoscope was used.
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Search Alerts/Recalls
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