APPLIED MEDICAL RESOURCES CD003, 5MM RETRIEVAL SYSTEM, 10/BX; LAPAROSCOPE, GENERAL & PLASTIC SURGERY
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Model Number CD003 |
Device Problem
Material Rupture (1546)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 12/01/2022 |
Event Type
malfunction
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Event Description
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Procedure performed: robotic assisted cholecystectomy.Event description: the rep was not present for the case.The inzii was inserted through an 8mm port site.After retrieval and during removal of the gallbladder specimen, the bag broke at the distal tip, leaving specimen inside patient cavity.The surgeon extended the incision in order to retrieve the specimen by hand.There was no bag fragmentation.There was no injury and the patient is okay.Intervention: extended incision to receive specimen.Patient status: no injury.
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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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Manufacturer Narrative
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The event unit was returned to applied medical for evaluation.Visual inspection confirmed the complainant's experience as the bag was torn at the tip.Stretching was also observed near the tear.Based on condition of the returned unit and the description of the event, it is likely that the incision size was not adequately enlarged prior to specimen removal, resulting in excessive force being exerted on the tip of the bag and causing the bag to tear.The instructions for use (ifu) states, "if the bag and its contents are too large to be extracted, carefully enlarge the port site for ease of bag removal.".
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Event Description
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Procedure performed: robotic assisted cholecystectomy.Event description: the rep was not present for the case.The inzii was inserted through an 8mm port site.After retrieval and during removal of the gallbladder specimen, the bag broke at the distal tip, leaving specimen inside patient cavity.The surgeon extended the incision in order to retrieve the specimen by hand.There was no bag fragmentation.There was no injury and the patient is okay.Intervention: extended incision to receive specimen.Patient status: no injury.
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