MERSILENE POLYESTER FIBER SUTURE
Received Mar 11, 2010 · Event occurred Jan 3, 2010
Report 2210968-2010-00166 · MDR key 1632438
Device
Generic name
Suture, Non-absorbable
Manufacturer
Ethicon, Inc.Model number
NACatalog number
RS22
Lot number
ALP016
Product problems
- Break
Patient
UNK
- Nonresorbable materials, unretrieved in body
Narrative
Additional Manufacturer Narrative
(B) (4). (B) (4). CONCLUSION: THE PRODUCT UPON WHICH THIS MEDWATCH IS BASED IN ANTICIPATED. ONCE THE PRODUCT IS RECEIVED, ANY FURTHER INFO DERIVED FROM THE EVAL WILL BE SUBMITTED IN A SUPPLEMENTAL 3500A FORM.
Description of Event or Problem
IT WAS REPORTED THAT A PT UNDERWENT A CERCLAGE PROCEDURE ON (B) (6) 2010. DURING THE PROCEDURE, THE TIP OF THE NEEDLE BROKE OFF WHILE GOING THROUGH THE CERVICAL TISSUE. AS THE PT IS PREGNANT, THE SURGEON ASSUMES THE NEEDLE PIECE REMAINS IN THE CERVIX BUT COULD NOT PERFORM AN X-RAY TO VERIFY. THE NEEDLE PIECE WAS MINUTE AND THE SURGEON HAS NO PLANS TO ATTEMPT REMOVAL. THE SURGEON PROCEED WITH THE CASE USING THE OTHER NEEDLE THAT WAS ON THE SUTURE.