SAFETY SCALPEL
Received Mar 29, 2019 · Event occurred Feb 26, 2019
Report 1060680-2019-00005 · MDR key 8464721
Device
Product problems
- Mechanical Problem
- Retraction Problem
- Mechanical Problem
- Retraction Problem
Patient
Not reported
- No Patient Involvement
- No Patient Involvement
Narrative
Additional Manufacturer Narrative
ROOT CAUSE: THE SCALPEL IS SUPPLIED TO DEROYAL BY S & S SURGICAL. THEREFORE, A SUPPLIER CORRECTIVE ACTION REQUEST (SCAR) WAS ISSUED TO S & S SURGICAL'S MANUFACTURER. IN ITS RESPONSE, THE MANUFACTURER STATED A ROOT CAUSE COULD NOT BE DETERMINED AS THE MACHINE AND INSPECTION SYSTEM ARE RUNNING PROPERLY. THE BOX LABELING STATES BLADES MAY BECOME EXPOSED DURING SHIPPING. TO FURTHER INVESTIGATE IF THE EXPOSED BLADES WERE CAUSED BY SOMETHING ELSE, THE MANUFACTURER WOULD NEED PHYSICAL SAMPLES. CORRECTIVE ACTION: DUE TO THE ROOT CAUSE DETERMINATION, A CORRECTIVE ACTION HAS NOT BEEN TAKEN. INVESTIGATION SUMMARY AN INTERNAL COMPLAINT (CALL 46472) WAS RECEIVED INDICATED THAT A SAFETY SCALPEL (PART NUMBER SM4511NS, LOT 012645) WAS NOT FULLY RETRACTED DURING INSPECTION. A BLADE WAS EXPOSED THUS CREATING A SAFETY HAZARD. THE DEFECTIVE DEVICE WAS NOT AVAILABLE FOR RETURN. HOWEVER, PHOTOS WERE PROVIDED THAT CONFIRM THE REPORTED EVENT. THE DEROYAL COMPLAINT INVESTIGATOR REVIEWED QUALITY RECORDS FOR POSSIBLE DISCREPANCIES THAT MAY HAVE CONTRIBUTED TO THE REPORTED EVENT. NO DISCREPANCIES WERE IDENTIFIED. THE SCALPEL IS SUPPLIED TO DEROYAL BY S & S SURGICAL. THEREFORE, A SCAR WAS ISSUED TO THE SUPPLIER'S MANUFACTURING ENTITY, CONTROLLED MOLDING, INC. A RESPONSE HAS BEEN RECEIVED AND ACCEPTED BY DEROYAL'S INVESTIGATOR. FROM JANUARY 2017 TO FEBRUARY 2019, DEROYAL HAS SOLD 2,481 CASES OF THE FINISHED GOOD. IN THAT SAME TIME, FIVE SIMILAR COMPLAINTS WERE IDENTIFIED, WHICH EQUATES TO A COMPLAINT-TO-SALES RATIO OF 0.202 PERCENT. DEROYAL WILL CONTINUE TO MONITOR POST MARKET FEEDBACK AND WILL RECOGNIZE IN THE FUTURE IF THE ISSUE REOCCURS. THE INVESTIGATION IS COMPLETE AT THIS TIME. IF NEW AND CRITICAL INFORMATION IS RECEIVED, THIS REPORT WILL BE UPDATED.
Description of Event or Problem
THE BLADES OF SAFETY SCALPELS WERE FOUND STICKING OUT DURING INSPECTION.
Additional Manufacturer Narrative
INVESTIGATION SUMMARY: AN INTERNAL COMPLAINT (CALL (B)(4)) WAS RECEIVED INDICATED THAT A SAFETY SCALPEL (PART NUMBER SM4511NS, LOT 012645) WAS NOT FULLY RETRACTED DURING INSPECTION. A BLADE WAS EXPOSED THUS CREATING A SAFETY HAZARD. THE DEFECTIVE DEVICE WAS NOT AVAILABLE FOR RETURN. HOWEVER, PHOTOS WERE PROVIDED THAT CONFIRM THE REPORTED EVENT. THE INVESTIGATION IS ONGOING AT THIS TIME. WHEN NEW AND CRITICAL INFORMATION IS RECEIVED, THIS REPORT WILL BE UPDATED.
Description of Event or Problem
THE BLADES OF SAFETY SCALPELS WERE FOUND STICKING OUT DURING INSPECTION.