Catalog Number 2B12LT |
Device Problems
Detachment Of Device Component (1104); Component Falling (1105)
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Patient Problem
No Consequences Or Impact To Patient (2199)
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Event Date 09/23/2015 |
Event Type
malfunction
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Manufacturer Narrative
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(b)(4).Information anticipated, but unavailable at this time.When additional information is received and/or the device analysis has been completed, a supplemental medwatch will be sent.
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Event Description
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It was reported that during a laparoscopic sigmoidectomy, the duck-billed valve fell off when the obturator was inserted into the outer sleeve since the duck-billed valve was not set properly.The device was not used for the patient.Another device was used to complete the case.There were no adverse consequences to the patient.
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Manufacturer Narrative
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(b)(4).Batch # m91p9n.The analysis results found that the 2b12lt device was returned in good condition.During visual inspection, the duckbill was observed to be in good condition and properly seated; upon mechanical testing no issues were noted.The device was fully functional according to the manufacturing requirements.No conclusion could be reached as to what may have caused the reported incident.This report is not intended to deny that you experienced a problem with the device.There may have been other circumstances or issues that occurred during the use of the device that we were unable to duplicate during our laboratory analysis.The batch record was reviewed and no anomalies were noted during the manufacturing process.
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Search Alerts/Recalls
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