BACKFLUSH INSTRUMENT WITH DIATHERMY, INCL. ACTIVE ASPIRATION. (23 GAUGE / 0.6 MM

Additional Manufacturer Narrative

THERE IS FOREIGN MATERIAL ATTACHED ON THE SHAFT PART. THE INVESTIGATION SHOWED THAT THE FOREIGN OBJECT ON THE SHAFT IS GLUE. THIS WILL BE REVIEWED WITH THE PRODUCTION DEPARTMENT TO FIND OUT HOW THIS HAS ESCAPED THE ATTENTION OF THE QUALITY CONTROL. DURING THE RETROSPECTIVE REVIEW, AND AS PER THE COMPLAINT DESCRIPTION, FOREIGN MATERIAL MAY LEAD TO SERIOUS HARM TO PATIENT, HENCE CONCLUDED AS REPORTABLE. THIS REPORTABLE EVENT WAS IDENTIFIED DURING A VOLUNTARY RETROSPECTIVE REVIEW OF ALL COMPLAINTS SINCE 2015 BY THE MANUFACTURER (DUTCH OPHTHALMIC RESEARCH CENTRE (B)(4)). DETAILS OF THIS ACTIVITY WERE DISCUSSED WITH CDRH OFFICE OF COMPLIANCE ((B)(6)) DURING A TELE-CONFERENCE ON (B)(6) 2017. NO INFORMATION REASONABLY SUGGESTS ANYONE WAS HARMED. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. THIS COMPLAINT HAS NOW BEEN CLOSED.

Description of Event or Problem

THERE IS FOREIGN MATERIAL ATTACHED ON THE SHAFT PART. NO REPORT OF INJURY. ALL INFORMATION HAS BEEN DISCLOSED.