BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OPC DERMATOLOGY SURGICAL PACK

    MDR report key: 18464112 · Received January 8, 2024

    Report

    Report Number
    3005011024-2024-00001
    Event Type
    Malfunction
    Date Received
    January 8, 2024
    Date of Event
    December 11, 2023
    Report Date
    April 26, 2024
    Manufacturer
    DEROYAL INDUSTRIES, INC.
    Product Code
    KDD
    UDI-DI
    00749756915281
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    A COMPLAINT WAS RECEIVED ON (B)(6)2023 REPORTING THE SKIN HOOK TIP BROKE OFF DURING USE. TIP HAD TO BE FISHED OUT OF INCISION. THE SAMPLE WAS NOT AVAILABLE TO BE RETURNED TO DEROYAL. A SUPPLIER CORRECTIVE ACTION REQUEST (SCAR) WAS ISSUED TO THE SKIN HOOK SUPPLIER FINE SURGICAL INSTRUMENT CORP. SUPPLIER FINE SURGICAL CORP. DETERMINED THERE WAS AN AREA WHICH COULD HAVE CONTRIBUTED TO THE SKIN HOOK BREAKING. SINCE THE WORKING AREA OF SKIN HOOK IS VERY DELICATE, IT MIGHT HAVE BEEN DAMAGED DURING THE PROCEDURE. THE FOLLOWING CORRECTIONS HAVE BEEN TAKEN BY THE SUPPLIER FINE SURGICAL CORP. TO ENSURE CORRECT MATERIAL COMPOSITION INSTRUMENTS WERE LAB TESTED TO ENSURE THE HARDNESS WAS ACCORDING TO SPECIFICATIONS. THE LAB RESULTS CONFIRMED THAT THE PRODUCTS TESTED WERE WITHIN THE REQUIRED SPECIFICATIONS. HOOKS WERE HANDLED WITH GREAT CARE THROUGHOUT THE PROCESS. ALL THE HOOKS POINT AREAS WERE COVERED WITH POINT PROTECTORS SO THAT NO DAMAGE OCCURRED DURING HANDLING AND TRANSPORTATION. THE FOLLOWING CORRECTIVE AND PREVENTIVE ACTIONS HAVE BEEN TAKEN BY FINE SURGICAL CORP. THE ENTIRE STOCK WAS 100% QUALITY CONTROL INSPECTED. ALL PERSONNEL INVOLVED IN MANUFACTURING, INSPECTION AND PACKING WERE RETRAINED SO THEY ARE AWARE OF THE REPORTED ISSUE AND THEIR CONSEQUENCES SO THAT THEY WOULD PAY SPECIAL ATTENTION TO THE PRODUCT. HOOKS WERE PRESS CHECKED AGAINST HARD OBJECTS DURING INSPECTION. ALL PIECES ARE REINSPECTED UNDER MAGNIFYING GLASSES TO COMPLETELY ENSURE THERE IS NO DAMAGED TIP. ALL PIECES UNDERGOING THESE PROCESSES ARE SUFFICIENTLY DURABLE TO ENDURE FUTURE UTILIZATION. ANOTHER TEAM WAS HIRED FOR PRE-SHIPPING 100% INSPECTION OF ALL THE PACKED MATERIAL. THIS ACTION IS TO FURTHER HELP PREVENT SUCH ERRORS HAPPENING AGAIN. PRODUCTION RECORDS WERE REVIEWED, AND NO ISSUES WERE FOUND. AN INVENTORY CHECK OF THE SKIN HOOK WAS MADE BY DEROYAL, A TOTAL OF 50 OF THE 1154327 WERE INSPECTED, AND NO DISCREPANCIES WERE IDENTIFIED DURING THE INSPECTION. THIS INVESTIGATION IS COMPLETE AT THIS TIME. NO FURTHER INFORMATION IS AVAILABLE AT THIS TIME. WE WILL PROVIDE FOLLOW-UP REPORT IF ADDITIONAL INFORMATION BECOMES AVAILABLE.

    Additional Manufacturer Narrative · 0

    A COMPLAINT WAS RECEIVED ON 12/11/2023 REPORTING THE SKIN HOOK TIP BROKE OFF DURING USE. TIP HAD TO BE FISHED OUT OF INCISION. THE SAMPLE IS NOT AVAILABLE FOR RETURNED TO DEROYAL. A SUPPLIER CORRECTIVE ACTION REQUEST (SCAR) WAS ISSUED TO THE SKIN HOOK SUPPLIER FINE SURGICAL INSTRUMENT CORP. THIS INVESTIGATION IS ONGOING AT THIS TIME. NO FURTHER INFORMATION IS AVAILABLE AT THIS TIME. WE WILL PROVIDE FOLLOW-UP REPORT IF ADDITIONAL INFORMATION BECOMES AVAILABLE.

    Description of Event or Problem · 0

    THE SKIN HOOK TIP BROKE OFF DURING USE. TIP HAD TO BE FISHED OUT OF INCISION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    950002 OPC DERMATOLOGY SURGICAL PACK KIT, SURGICAL INSTRUMENT, DISPOSABLE KDD DEROYAL INDUSTRIES, INC. 89-9584 00749756915281

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown