APPLIED MEDICAL RESOURCES CTB03, 5X100 KII SH BLD ZTHR 6/BX; LAPAROSCOPE, GENERAL & PLASTIC SURGERY
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Model Number CTB03 |
Device Problem
Dull, Blunt (2407)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 06/11/2021 |
Event Type
malfunction
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Manufacturer Narrative
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The event device is anticipated to be returned to applied medical for evaluation.A follow-up report will be provided upon completion of the investigation.
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Event Description
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Procedure performed: laparoscopic cholecystectomy.Event description: for the second trocar, the blade of the introducer appeared too dull to cut through tissue safely toe enter the patient.Packaging included for second trocar in case that was the issue and not the introducer.Product is available for return.Additional information received via email on 18jun2021 from [user facility]: the blade dullness was first noted, "when dr.[name] tried to put in the second trocar.After three attempts she asked for a new trocar and to do the non-conforming product paperwork on the one that appeared dull.Note that it was a different trocar than what came with the introducer." the dull introducer came from a different trocar than the one that was being inserted into the patient at the time of the event.The trocar being inserted was a cts02, the lot number is unknown.The case was completed by using another ctb03.Intervention: the case was completed by using another ctb03.Patient status: patient not affected.
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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 of a dull blade, the tip of the blade was damaged.Based on the condition of the returned unit and the description of the event, it is likely that the blade was damaged during the procedure, prior to the second insertion, as no malfunction was reported with the first insertion using the blade.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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Event Description
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Procedure performed: laparoscopic cholecystectomy.Event description: for the second trocar, the blade of the introducer appeared too dull to cut through tissue safely to enter the patient.Packaging included for second trocar in case that was the issue and not the introducer.Product is available for return.Additional information received via email on (b)(6) 2021 from [user facility]: the blade dullness was first noted, "when dr.[name] tried to put in the second trocar.After three attempts she asked for a new trocar and to do the non-conforming product paperwork on the one that appeared dull.Note that it was a different trocar than what came with the introducer." the dull introducer came from a different trocar than the one that was being inserted into the patient at the time of the event.The trocar being inserted was a cts02, the lot number is unknown.The case was completed by using another ctb03.Additional information received via email on (b)(6) 2021 from [user facility]: yes the obturator/introducer was successfully used during the first insertion during the case.Intervention: the case was completed by using another ctb03.Patient status: patient not affected.
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Search Alerts/Recalls
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