BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TROCLEAN, 5-7MM & 7-12MM

    MDR report key: 19950930 · Received August 9, 2024

    Report

    Report Number
    1060680-2023-00012
    Event Type
    Malfunction
    Date Received
    August 9, 2024
    Date of Event
    August 28, 2023
    Report Date
    October 27, 2023
    Manufacturer
    SUPER BRUSH LLC
    Product Code
    GEA
    UDI-DI
    50749756912827
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    A SUPPLIER CORRECTIVE ACTION REQUEST (SCAR) WAS ISSUED TO THE SUPPLIER, SUPERBRUSH LLC. DEROYAL INVESTIGATED INVENTORY AND FOUND THAT ALL WERE WITHIN SPECIFICATION. A COMPLAINT TO SALES RATIO WAS CALCULATED FROM JUNE 2021 TO AUGUST 2023 AND FOUND TO BE (B)(4). ROOT CAUSE: BECAUSE THE SAMPLE WAS UNABLE TO BE RETURNED, THE ROOT CAUSE OF THE COMPLAINT WAS UNABLE TO BE DETERMINED. CORRECTIVE AND PREVENTIVE ACTION: AN UPDATE TO LABELING WAS MADE TO CLARIFY THE SIZES OF TROCARS TO BE USED WITH THE SMALL AND LARGE SIZE BRUSHES. DEROYAL WILL CONTINUE TO MONITOR FOR TRENDS AROUND THIS ITEM AND ISSUE. 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 USER FACILITY REPORTED, "(B)(6) WAS SWABBING A TROCAR RATHER VIGOROUSLY AND WHEN SHE WENT TO PULL IT OUT THE TIP POPPED OFF FALLING INTO THE PATIENT'S ABDOMEN. TEAM ADDED THAT THE SWABS SEEM LIKE THEY ARE NOT ATTACHED AS WELL TO THE STICK AS THEY USED TO BE." DEROYAL INDUSTRIES REQUESTED RETURN OF THE SAMPLE, BUT IT WAS STATED THAT IT COULD NOT BE RETURNED. THIS INVESTIGATION IS NOT COMPLETE AT THIS TIME. NO FURTHER INFORMATION IS AVAILABLE AT THIS TIME. WE WILL PROVIDE FOLLOW-UP REPORT WHEN ADDITIONAL INFORMATION BECOMES AVAILABLE.

    Description of Event or Problem · 0

    A USER FACILITY REPORTED, "(B)(6) WAS SWABBING A TROCAR RATHER VIGOROUSLY AND WHEN SHE WENT TO PULL IT OUT THE TIP POPPED OFF FALLING INTO THE PATIENT'S ABDOMEN. TEAM ADDED THAT THE SWABS SEEM LIKE THEY ARE NOT ATTACHED AS WELL TO THE STICK AS THEY USED TO BE."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2200096 TROCLEAN, 5-7MM & 7-12MM CANNULA, SURGICAL, GENERAL & PLASTIC SURGERY GEA SUPER BRUSH LLC 28-1002 58093641 50749756912827

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown