NEURO SPNG-1/2X3"-STRL- 20/CS

Description of Event or Problem

A USER FACILITY REPORTED, "PRODUCT USED IN ENDOSCOPIC SINUS SURGERY WITH EPINEPHRINE. SMALL FIBERS WERE LEFT BEHIND IN NASAL CAVITY WHEN SPONGES WERE REMOVED."

Additional Manufacturer Narrative

A USER FACILITY REPORTED, "PRODUCT USED IN ENDOSCOPIC SINUS SURGERY WITH EPINEPHRINE. SMALL FIBERS WERE LEFT BEHIND IN NASAL CAVITY WHEN SPONGES WERE REMOVED." DEROYAL INDUSTRIES, INC. REQUESTED RETURN OF THE DEVICE, BUT IT HAS YET TO BE RECEIVED. A SUPPLIER CORRECTIVE ACTION REQUEST (SCAR) HAS BEEN ISSUED TO THE SUPPLIER, MEDSORB DOMINICANA, S.A. THIS INVESTIGATION IS NOT COMPLETE AT THIS TIME. NO FURTHER INFORMATION IS AVAILABLE AT THIS TIME. WE WILL PROVIDE FOLLOW UP REPORT WHEN ADDITIONAL INFORMATION BECOMES AVAILABLE.

Additional Manufacturer Narrative

A USER FACILITY REPORTED, "PRODUCT USED IN ENDOSCOPIC SINUS SURGERY WITH EPINEPHRINE. SMALL FIBERS WERE LEFT BEHIND IN NASAL CAVITY WHEN SPONGES WERE REMOVED." DEROYAL INDUSTRIES, INC. REQUESTED RETURN OF THE DEVICE, BUT IT WAS NOT RECEIVED. THE DEVICE HISTORY RECORD WAS REVIEWED AND NO ISSUES WERE FOUND. DEROYAL REVIEWED INVENTORY ON HAND AND DID NOT FIND ANY ISSUES WITH THE FIBERS. A COMPLAINT TO SALES RATIO WAS CONDUCTED OVER THE PAST TWO YEARS AND FOUND TO BE (B)(4). A SUPPLIER CORRECTIVE ACTION REQUEST (SCAR) HAS BEEN ISSUED TO THE SUPPLIER, (B)(4). THE SUPPLIER REVIEWED THEIR DEVICE HISTORY RECORD, COMPLAINT RECORDS, AND INTENDED USE VERIFICATION. THE DEVICE HISTORY RECORD REVIEWED DID NOT IDENTIFY ANY ISSUES WITHIN MANUFACTURING. IT WAS REVIEWED THAT THE COMPLAINT STATED THAT THE PRODUCT WAS USED IN A SINUS SURGERY WHICH IS NOT WITHIN THE SCOPE OF THE INTENDED USE WHICH SHOULD ONLY BE USED FOR NEUROLOGICAL PROCEDURES. ROOT CAUSE: THE PRODUCT WAS USED IN AN ENDOSCOPIC SINUS SURGERY, WHICH IS OUTSIDE THE INTENDED USE. THE PRODUCT IS INTENDED FOR NEUROLOGICAL PROCEDURES ONLY. USE IN A DIFFERENT ANATOMICAL SITE, LIKE NASAL CAVITY, MAY RESULT IN UNINTENDED INTERACTION WITH TISSUE, INCLUDING THE PERCEPTION OF FIBER RESIDUE. CORRECTIVE OR PREVENTIVE ACTIONS: BECAUSE THE CAUSE WAS TRACED TO USER ERROR, NO CORRECTIVE OR PREVENTIVE ACTIONS WERE TAKEN. DEROYAL WILL CONTINUE TO MONITOR FOR TRENDS AROUND THIS ITEM AND ISSUE. THIS INVESTIGATION IS COMPLETE AT THIS TIME. NO FURTHER INFORMATION IS AVAILABLE AT THIS TIME. WE WILL PROVIDE FOLLOW UP REPORT IF ADDITIONAL INFORMATION BECOMES AVAILABLE.