ETHIBOND EXTRA & EXCEL POLYESTER SUTURE
Received Nov 1, 2011 · Event occurred Oct 9, 2011
Report 2210968-2011-01697 · MDR key 2318009
Device
Generic name
Suture, Nonabsorbable
Manufacturer
Ethicon. Inc.Model number
NACatalog number
W6767
Lot number
DD2DQZN0
Product problems
- Break
Patient
Not reported
- Nonresorbable materials, unretrieved in body
Narrative
Description of Event or Problem
IT WAS REPORTED THAT A PATIENT UNDERWENT A GASTRIC BYPASS PROCEDURE ON (B)(6) 2011 AND SUTURE WAS USED. THE SUTURE BROKE DURING KNOTTING AND THE NEEDLE DISAPPEARED WITH PART OF THE SUTURE INSIDE THE PATIENT. AN X RAY WAS DONE TO LOCATE THE NEEDLE BUT WITH NO SUCCESS. THE PATIENT WAS OBESE AND IT WAS TOO DIFFICULT TO FIND THE NEEDLE.
Additional Manufacturer Narrative
(B)(4). CONCLUSION: NO CONCLUSION CAN BE DRAWN AT THIS TIME. SHOULD ADDITIONAL INFORMATION BE OBTAINED, A SUPPLEMENTAL 3500A FORM WILL BE SUBMITTED ACCORDINGLY. IN ADDITION, A REVIEW OF THE BATCH MANUFACTURING RECORDS WAS CONDUCTED AND THE BATCH MET ALL FINISHED GOODS RELEASE CRITERIA.
Remedial action
- Other