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Model Number CNO12 |
Device Problem
Detachment Of Device Component (1104)
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Patient Problem
No Consequences Or Impact To Patient (2199)
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Event Date 09/12/2016 |
Event Type
malfunction
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Manufacturer Narrative
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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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"during procedure the sealguard (clear plastic internal piece) detached and was pushed through cannula causing loss of pneumo.Instruments being used were angled graspers, angled 10mm 45 degree scope, angle point cautery, straight graspers and suction-irrigation.No harm to patient." patient status: "no harm to patient.".
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Manufacturer Narrative
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The event unit was not returned for evaluation.In the absence of the subject device, it is difficult to determine the root cause.The most likely root cause of the trocar shield dislodgement is the insertion of an angular or bent instrument.The instructions for use (ifu), warns that "extra care should be used when inserting angular and asymmetrical instruments." all instruments should be centered axially when inserted through the shield to prevent dislodgement.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 to 21 cfr 803.56, if additional information is obtained which was not known or was not available when this report was submitted, a supplemental report will be submitted to the fda.
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Search Alerts/Recalls
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