SAFETY SCALPEL

Additional Manufacturer Narrative

ROOT CAUSE: THE SCALPEL IS SUPPLIED TO DEROYAL BY S & S SURGICAL. A SUPPLIER CORRECTIVE ACTION REPORT WAS ISSUED TO S & S SURGICAL. IN ITS RESPONSE, THE SUPPLIER STATED THAT A ROOT CAUSE COULD NOT BE DETERMINED. THE SAMPLE WAS NOT RETURNED FOR EVALUATION. THE MACHINE AND INSPECTION SYSTEM WERE FOUND TO BE FUNCTIONING PROPERLY. TO INVESTIGATE FURTHER, THE PHYSICAL SAMPLE IS NEEDED. THE BOX IS LABELED THAT THE BLADES MAY BECOME EXPOSED DURING SHIPPING. CORRECTIVE ACTION: NO CORRECTIVE ACTION WAS TAKEN BASED ON THE ROOT CAUSE DETERMINATION. INVESTIGATION SUMMARY AN INTERNAL COMPLAINT (CALL 47190) WAS RECEIVED FOR A SCALPEL (PART SM4511NS) WITH AN EXPOSED BLADE, RESULTING IN AN INJURY WHEN UNPACKING A BAG. A PHYSICAL SAMPLE WAS NOT AVAILABLE FOR RETURN. PHOTOS WERE PROVIDED OF THE REPORTED ISSUE. THE WORK ORDER WAS CHECKED AND SHOWED NO DISCREPANCIES THAT MAY HAVE CONTRIBUTED TO THE REPORTED EVENT. THERE WAS NO STOCK ON HAND TO CHECK. THE SCALPEL IS SUPPLIED TO DEROYAL BY S & S SURGICAL. A SUPPLIER CORRECTIVE ACTION REPORT (SCAR) WAS ISSUED TO S & S SURGICAL. THE RESPONSE WAS RECEIVED AND ACCEPTED MAY 21, 2019 BY DEROYAL PERSONNEL. THE SUPPLIER ADDS A WARNING LABEL TO THE BOX WHICH STAYS ON THE PRODUCT WHEN SHIPPED FOR COMMERCIAL DISTRIBUTION. THIS LABEL STATES THE FOLLOWING: "WARNING - DO NOT REACH HAND INTO BOX. BLADES MAY BECOME EXPOSED DURING SHIPMENT." SINCE APRIL 2017, A TOTAL OF (B)(4) UNITS HAVE BEEN SOLD WITH A SALES-TO-COMPLAINT RATIO OF (B)(4). THERE HAVE BEEN FIVE COMPLAINTS DURING THIS TIME FRAME. THE INVESTIGATION IS COMPLETE AT THIS TIME. IF NEW AND CRITICAL INFORMATION IS RECEIVED, THIS REPORT WILL BE UPDATED.

Description of Event or Problem

EMPLOYEE WAS REMOVING SCALPEL FROM INNER BAG AND WAS STABBED BY THE SCALPEL.