BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SAFETY SCALPEL

    MDR report key: 7957494 · Received October 11, 2018

    Report

    Report Number
    2320762-2018-00005
    Event Type
    Malfunction
    Date Received
    October 11, 2018
    Date of Event
    September 11, 2018
    Report Date
    October 11, 2018
    Manufacturer
    S & S SURGICAL
    Product Code
    GDZ
    UDI-DI
    50749756645381
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

    ROOT CAUSE: A DEFINITIVE ROOT CAUSE HAS NOT BEEN DETERMINED. HOWEVER, THE FOLLOWING POSSIBLE ROOT CAUSES HAVE BEEN IDENTIFIED: THE OUTSIDE PROCESSOR DID NOT ENSURE THE SCALPEL WAS LOCKED IN PLACE BEFORE PACKAGING INTO THE POLY BAG OR THE SCALPEL WAS EXPOSED TO FORCE DURING SHIPPING THAT CAUSED THE HANDLE TO UNLOCK AND THE BLADE TO BECOME EXPOSED. CORRECTIVE ACTION: PACKAGING AND LABELING PERSONNEL WERE NOTIFIED OF THE REPORTED ISSUE. INVESTIGATION SUMMARY: AN INTERNAL REPORT (B)(4)) WAS RECEIVED INDICATING A SAFETY SCALPEL (PART D4511A) CONTAINED A BLADE THAT WAS LOOSE AND NOT SECURE INSIDE THE SCALPEL. THE CUSTOMER RETURNED FIVE CASES (500 EACH) FOR EVALUATION. ALL FIVE CASES WERE OPENED AND INSPECTED. OF THE 500 EACH, ONE BLADE WAS SEEN PROTRUDING FROM A SCALPEL HANDLE. THE LOCKING MECHANISM OF THIS SCALPEL AS WELL AS 19 OTHERS WERE CHECKED, AND ALL WERE FOUND TO BE FUNCTIONING CORRECTLY. ADDITIONALLY, ALL FIVE CASES WERE SEEN TO HAVE A STICKER ON THE BOX STATING THEY WERE "RELEASED." A REVIEW OF THE DEVICE HISTORY RECORD SHOWED NO DISCREPANCIES RELATED TO THE REPORTED ISSUE. RAW MATERIAL AND FINISHED GOOD INVENTORY FOUND NO INVENTORY WITH LOOSE OR EXPOSED BLADES. THE SCALPELS ARE SUPPLIED TO DEROYAL BE (B)(6) SURGICAL. THE COMPLAINT INVESTIGATOR DID NOT NOTIFY THE SUPPLIER OF THE REPORTED ISSUE BECAUSE THE INVESTIGATOR DETERMINED THE EXPOSED BLADE WAS NOT A MALFUNCTION OR DEFECT OF THE SCALPEL. THE LOCKING MECHANISMS OF THE SCALPELS WERE CHECKED AND ALL WERE FOUND TO BE FUNCTIONING CORRECTLY. AN OUTSIDE OPERATION PACKAGES THE SCALPELS INTO POLY BAGS, CLOSES THE BAGS WITH TWIST TIES, AND PLACES THESE BAGS INTO INDIVIDUAL BOXES TO BE SHIPPED TO DEROYAL. THIS OUTSIDE OPERATION WAS NOTIFIED OF THE REPORTED ISSUE AS WELL AS PERSONNEL AT DEROYAL'S MANUFACTURING FACILITY WHERE INSPECTION IS PERFORMED. DEROYAL (B)(4). DEROYAL WILL CONTINUE TO MONITOR POST-MARKET FEEDBACK AND WILL RECOGNIZE IN THE FUTURE IF A TREND DEVELOPS. THE INVESTIGATION IS COMPLETE AT THIS TIME. IF NEW AND CRITICAL INFORMATION BECOMES AVAILABLE, THIS REPORT WILL BE UPDATED.

    Description of Event or Problem · 1

    THE BLADE IS LOOSE, NOT SECURED INSIDE THE SCALPEL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    798998 SAFETY SCALPEL HANDLE, SCALPEL GDZ S & S SURGICAL D4511A 47881028 50749756645381

    Patients

    Seq Age Sex Outcome Treatment
    1