APPLIED MEDICAL RESOURCES CD004, 12/15MM RETRIEVAL SYSTEM, 5/BX; LAPAROSCOPE, GENERAL & PLASTIC SURGERY
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Model Number CD004 |
Device Problem
Material Rupture (1546)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 03/16/2023 |
Event Type
malfunction
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Manufacturer Narrative
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No product is being returned for evaluation and no lot number has been provided to applied medical.A follow-up report will be provided upon completion of investigation.
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Event Description
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Procedure performed: thymectomy.Event description: specimen had been placed into the retrieval bag without complication.Large, solid tumour.When surgeon attempted to remove tumour through intercostal space, there was insufficient space to pass the specimen through.In an attempt to remove the tumour through the intercostal space/ribs, substantial force was required and as dr [name] was pulling the bag, it broke at the reinforced tip.Intervention: surgeon separated the ribs using a rib spreader and removed the specimen without any retrieval bag.Patient status: no patient injury, fully recovered.
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Event Description
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Procedure performed: thymectomy.Event description: specimen had been placed into the retrieval bag without complication.Large, solid tumour.When surgeon attempted to remove tumour through intercostal space, there was insufficient space to pass the specimen through.In an attempt to remove the tumour through the intercostal space/ribs, substantial force was required and as dr was pulling the bag, it broke at the reinforced tip.Intervention: surgeon separated the ribs using a rib spreader and removed the specimen without any retrieval bag.Patient status: no patient injury, fully recovered.
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Manufacturer Narrative
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The event unit was not returned to applied medical for evaluation.As the event unit was not returned, applied medical was unable to determine if the event unit exhibited any non-conformances that could have contributed to the reported event.Based on the description of the event, it is likely that the tissue bag experienced excess stress when being pulled between the ribs and/or if the port site was not enlarged prior to removing the specimen.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." 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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