Device broke, no injury or delay in procedure was reported.Two device involved, they consist of the following: 1) tenaculum (8370.26), report: 1418479-2014-00020; 2) tenaculum (8370.26), report: 1418479-2014-00021.
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Handle is manufactured by richard wolf.It is then sent to endoplus where they manufacture and attach the insulated sheath and forceps.Completed device is then returned to richard wolf for distribution.An investigation was completed as the actual device was returned to the rwmic facility on (b)(4) 2013.Device was then sent to endoplus for additional investigation.Investigation revealed incorrect handle had been assembled on forceps.Manufacture date: nov 2011.Richard wolf considers this matter closed.However, in the event we receive additional information, we will provide fda with follow-up information.
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