Catalog Number B12LT |
Device Problem
Break (1069)
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Patient Problem
No Consequences Or Impact To Patient (2199)
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Event Date 05/18/2018 |
Event Type
malfunction
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Manufacturer Narrative
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(b)(4).Batch # unk.Attempts have been made to retrieve the device.To date the device has not been returned.If the device or further details are received at a later date a supplemental medwatch will be sent.The device history records were reviewed and the manufacturing criteria were met prior to the release of this lot.
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Event Description
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Duck seal damaged.During the endoscopic rectal cancer surgery, could not insert the obturator into the obturator sleeve.Checked the device, found the duck seal was not separated.Another device was used to complete the surgery.There were no adverse consequences to the patient.
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Manufacturer Narrative
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(b)(4).Batch # r92e90.Device analysis: the analysis results found that b12lt device was returned with no damage in the external components.In an attempt to replicate the reported incident the device was tested for functionality.Upon testing the obturator was attempted to be introduced into the sleeve assembly however it could not be introduced due to a closed duckbill and torn.This condition is most likely related to the manufacturing process.The reported complaint was confirmed.The batch history record was reviewed and no defects, ncr¿s or protocols related to the complaint, were found during the manufacturing process.
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Search Alerts/Recalls
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