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 08/01/2023 |
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: cholecystectomy.Event description: complaint 1 of 2: (b)(4).Complaint 2 of 2: (b)(4).Translation: when placing the clip on the cystic artery: 1st clip out, then stop.Subsequent clips no longer advance on the rail.When they come out, they are closed.2 clips = identical problem.Patient's current condition: need for another clip.Only 1 of 20 clips in the clip.Patient status: ok intervention: device replacement.
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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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Event Description
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Procedure performed: cholecystectomy.Event description: complaint 1 of 2: (b)(4).Complaint 2 of 2: (b)(4).Translation: when placing the clip on the cystic artery: 1st clip out, then stop.Subsequent clips no longer advance on the rail.When they come out, they are closed.2 clips = identical problem.Patient's current condition: need for another clip.Only 1 of 20 clips in the clip.Patient status: ok.Intervention: device replacement.
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Search Alerts/Recalls
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