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 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: unknown.Event description: the event date is unknown.Email has implied a previous event (two issues) where the kii threaded bladed trocar has not functioned correctly for unknown reasons and it is also unknown when this happened.These event are recorded in applied medical reference numbers 2019-002112 and 2019-002113.Below email received on (b)(6) 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." patient status: no injury occured.
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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, testing was unable to be performed and the complainant's experience could not be confirmed or replicated.In the absence of the event unit, it is difficult to determine the exact root cause of the event.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: unknown.Event description: the event date is unknown.Email has implied a previous event (two issues) where the kii threaded bladed trocar has not functioned correctly for unknown reasons and it is also unknown when this happened.These event are recorded in applied medical reference numbers (b)(4) (report # 2027111-2019-00577) and (b)(4) (report # 2027111-2019-00578).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." patient status: no injury occured.
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Search Alerts/Recalls
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