APPLIED MEDICAL RESOURCES C4120, 38CM LATIS GRASPER CART, 10/BX; LAPAROSCOPIC ACCESSORIES, GYNECOLOGIC
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Model Number C4120 |
Device Problem
Mechanical Jam (2983)
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Patient Problem
No Consequences Or Impact To Patient (2199)
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Event Date 08/23/2020 |
Event Type
malfunction
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Manufacturer Narrative
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Ra has just received the incident device and has been assigned to engineering for evaluation.A follow-up report will be sent upon completion of investigation.
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Event Description
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Procedure performed: ni.Additional information received via email from [name] 27.08.2020: i still don¿t have a detailed description, but was told briefly that the jaws couldn't close after opening inside the patient, so the grasper couldn¿t be removed via the port, so had to remove both grasper and port together.When i hear back i can add further comment.Intervention: ni.Patient status: patient is fine, and completely unaffected.
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Event Description
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Procedure performed: ni.Additional information received via email from [name] 27.08.2020: i still don¿t have a detailed description, but was told briefly that the jaws couldn¿t close after opening inside the patient, so the grasper couldn¿t be removed via the port, so had to remove both grasper and port together.When i hear back i can add further comment.Intervention: ni.Patient status: patient is fine, and completely unaffected.
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Manufacturer Narrative
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The event unit along with one 5mm trocar was returned to applied medical for evaluation.Visual inspection of the event unit confirmed that the jaws were unable to be closed and removed from the trocar.Engineering also observed that the formed end of the rivet had partially dislodged from the jaws.Based on the condition of the returned unit, the reported event was caused by the formed end of the rivet that came out of place while the device was being used.The probability and criticality of harm resulting from this failure have been evaluated and were found to be at an acceptable level.
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