Catalog Number 2CB12LT |
Device Problem
Mechanical Jam (2983)
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Patient Problem
No Consequences Or Impact To Patient (2199)
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Event Date 10/04/2019 |
Event Type
malfunction
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Manufacturer Narrative
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(b)(4).Batch # unk.A manufacturing record evaluation was performed for the finished device lot number and no non-conformances were identified.
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Event Description
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It was reported that during set-up for a lap nephrectomy case and prior to the trocar being inserted into the patient, the trocar would not go through the sleeve.Staff noticed that it was jammed due to the internal sleeve on the trocar being broken.A second trocar was used in place of the damaged one.There was no patient consequence.
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Manufacturer Narrative
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(b)(4).Batch # unk.Investigation summary: the analysis results found that 2cb12lt device was received with the absorbent not properly assembled on the sleeve housing.Complaint was confirmed.A manufacturing record evaluation was performed for the finished device lot number, and no non-conformances were identified.
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Manufacturer Narrative
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(b)(4).Corrected data: batch # is t40r0p.A manufacturing record evaluation was performed for the finished device lot/batch number and no non-conformances were identified.
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Search Alerts/Recalls
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