#11 SAFETY SCALPEL

Additional Manufacturer Narrative

ROOT CAUSE: THE REPORTED ISSUE HAS BEEN DETERMINED TO BE AN ATTENTION-BASED ERROR BY THE END USER. DEROYAL PROVIDES INSTRUCTIONS FOR USE WITH THE DEVICE AND WITHIN THE DIRECTIONS FOR USE SECTION ARE SPECIFIC INSTRUCTIONS FOR PRODUCT USE. CORRECTIVE ACTION: A CORRECTIVE ACTION HAS NOT BEEN TAKEN. INVESTIGATION SUMMARY: AN INTERNAL COMPLAINT ((B)(4)) WAS RECEIVED INDICATING THAT THE REPORTING CUSTOMER IS HAVING ISSUES WITH A SAFETY SCALPEL (FINISHED GOOD (B)(4), LOT NUMBER 40418006). ACCORDING TO THE CUSTOMER'S REPORT, THE SURGEON PICKED UP THE SCALPEL, AND WITHOUT LOOKING CLOSELY AT IT, PRESSED THE BUTTON AND STABBED HER PALM. DEROYAL SUPPLIES INSTRUCTIONS FOR USE WITH THE PRODUCT. UNDER THE DIRECTIONS FOR USE, INSTRUCTIONS ARE PROVIDED FOR HANDLING AND USAGE OF THE DEVICE. STEP 2 STATES, "GRASP THE SCALPEL AND CAREFULLY EXTEND THE BLADE BY MOVING THE BLUE SLIDE TOWARD THE TIP OF THE SCALPEL, USING THE THUMB OF THE HAND HOLDING THE SCALPEL." THE DESIGN OF THE PRODUCT CLEARLY IDENTIFIES THE DIRECTION OF THE BLADE AND MOVEMENT OF THE SLIDER. ONE END OF THE RED HANDLE IS CLOSED AND THE OTHER, OPENED SO THE BLADE CAN EXTEND. WHEN RETRACTED, THE BLUE SLIDER IS POSITIONED TOWARD THE CLOSED END OF THE HANDLE. IN THIS POSITION, THE SLIDER CAN ONLY MOVE UPWARD TOWARD THE OPENED END OF THE HANDLE TO EXTEND THE BLADE. DEROYAL HAS SOLD (B)(4) EACH OF FINISHED GOOD (B)(4) FROM 2014 TO PRESENT. DURING THIS SAME PERIOD, (B)(4) COMPLAINTS WERE RECEIVED FOR SCALPEL STICKS OR CUTS. THIS IS A COMPLAINT-TO-SALES RATIO OF (B)(4) PERCENT. DEROYAL WILL CONTINUE TO MONITOR POST MARKET FEEDBACK AND WILL RECOGNIZE IN THE FUTURE IF A TREND DEVELOPS. PREVENTIVE ACTION: DUE TO THE INVESTIGATION AND ROOT CAUSE, A PREVENTIVE ACTION HAS NOT BEEN TAKEN. THE INVESTIGATION IS COMPLETE. IF NEW AND CRITICAL INFORMATION IS RECEIVED, THIS REPORT WILL BE UPDATED. DEVICE NOT RETURNED.

Description of Event or Problem

DURING A BREAST STEREOTACTIC BIOPSY, THE CLINICIAN PICKED THE SAFETY SCALPEL UP OFF THE TRAY. WITHOUT LOOKING CLOSELY AT THE SCALPEL, THE CLINICIAN PRESSED THE BUTTON AND IT STABBED INTO HER PALM. THE RESULTING INJURY WAS NOT VERY DEEP AND DID NOT REQUIRE STITCHES.