BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SAFETY SCALPEL

    MDR report key: 8464721 · Received March 29, 2019

    Report

    Report Number
    1060680-2019-00005
    Event Type
    Malfunction
    Date Received
    March 29, 2019
    Date of Event
    February 26, 2019
    Report Date
    April 22, 2019
    Manufacturer
    S & S SURGICAL
    Product Code
    GDZ
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    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 · 0

    THE BLADES OF SAFETY SCALPELS WERE FOUND STICKING OUT DURING INSPECTION.

    Additional Manufacturer Narrative · 1

    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 · 1

    THE BLADES OF SAFETY SCALPELS WERE FOUND STICKING OUT DURING INSPECTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    259691 SAFETY SCALPEL HANDLE, SCALPEL GDZ S & S SURGICAL SM4511NS 012645

    Patients

    Seq Age Sex Outcome Treatment
    1