Model Number CTB03 OR CTB73 |
Device Problem
Retraction Problem (1536)
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Patient Problem
No Consequences Or Impact To Patient (2199)
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Event Date 08/20/2019 |
Event Type
malfunction
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Manufacturer Narrative
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The event unit will not be returned to applied medical for evaluation.A follow-up report will be submitted upon completion of investigation.
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Event Description
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Procedure performed: laparoscopic bilateral salpingo oophorectomy.Event description: below email received on 21st august 2019 from user facility rep: now i am afraid than mr [name] has had two issues with the trocars.They have not retracted.One caused slight bowel damage and resulted in him raising it as a safety issue.I appreciate that mr [name] refused training, refused to have you in his theatre and indeed, was not pleasant went you tried to speak to him.I went to visit [user facility rep] today at [] hospital.In this case where mr [name] had with the bladed trocar, the patient is fine, and only has bruising on the bowel.The procedure was a laparoscopic bilateral oophorectomy.The staff did not retain the device as they went straight into the sharps bin and the staff did not want to put their hands in understandably.Trocars used were the ctb73 and ctb03.The lot and serial are unknown at this stage.She was unable to tell me exactly what happened in this case and for which trocar.Patient status: patient is ok, bruising to the bowel only.
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Manufacturer Narrative
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The event unit was not returned to applied medical for evaluation.In the absence of the event unit, it is difficult to determine the exact root cause of the event.Applied medical has reviewed the details surrounding the event and related products.At this time, applied medical is unable to determine the cause of the injury or confirm that a product malfunction occurred.
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Event Description
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Procedure performed: laparoscopic bilateral salpingo oophorectomy.Event description: below email received on 21st august 2019 from user facility rep: now i am afraid than mr [name] has had two issues with the trocars.They have not retracted.One caused slight bowel damage and resulted in him raising it as a safety issue.I appreciate that mr [name] refused training, refused to have you in his theatre and indeed, was not pleasant went you tried to speak to him.I went to visit [user facility rep] today at hospital.In this case where mr [name] had with the bladed trocar, the patient is fine, and only has bruising on the bowel.The procedure was a laparoscopic bilateral oophorectomy.The staff did not retain the device as they went straight into the sharps bin and the staff did not want to put their hands in understandably.Trocars used were the ctb73 and ctb03.The lot and serial are unknown at this stage.She was unable to tell me exactly what happened in this case and for which trocar.Patient status: patient is ok, bruising to the bowel only.
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Search Alerts/Recalls
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