Model Number CA500 |
Device Problem
Failure to Fire (2610)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 12/09/2023 |
Event Type
malfunction
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Manufacturer Narrative
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The event unit is anticipated to return to applied medical.A follow up report will be provided following the completion of the investigation.
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Event Description
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Procedure performed: lap.Chole.Event description: the doctor tried to set a second clip (he pulled the trigger plastic to plastic).Only the first clip came out.No further clip came by pulling the trigger again.No clinical impact to the patient.He opened a new ca500.Our trocars (cff03) and a grasper were used.Patient status: all right.Intervention: he opened a new ca500.
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Event Description
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Procedure performed: lap.Chole.Event description: the doctor tried to set a second clip (he pulled the trigger plastic to plastic).Only the first clip came out.No further clip came by pulling the trigger again.No clinical impact to the patient.He opened a new ca500.Our trocars (cff03) and a grasper were used.Patient status: all right.Intervention: he opened a new ca500.
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Manufacturer Narrative
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Applied medical has issued a voluntary recall of our epix universal clip applier for specific ca500 lots.These ca500 units are being recalled due to a nonconformance that may result in a clip not loading into the jaws after the trigger is actuated.Applied medical has recently implemented manufacturing corrections which are intended to reduce the potential for this type of incident to reoccur.The lot associated with this complaint, #(b)(4), was included in the recall.
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Search Alerts/Recalls
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