BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SM OR-DR. YEH PACK-LF

    MDR report key: 22826512 · Received August 18, 2025

    Report

    Report Number
    1423395-2025-00091
    Event Type
    Injury
    Date Received
    August 18, 2025
    Date of Event
    July 18, 2025
    Report Date
    August 18, 2025
    Manufacturer
    MEDLINE INDUSTRIES, LP
    Product Code
    LRO
    UDI-DI
    10198459164460
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    ACCORDING TO THE CUSTOMER, SMALL WHITE FRAGMENTS OF THE CLIP HOLDER MATERIAL HAVE BEEN COMING OFF WITH THE CLIP WHEN LOADED INTO THE CLIP APPLIERS SEVERAL TIMES. THE CUSTOMER REPORTED THAT ON (B)(6) 2025, THE SURGEON HAD TO REMOVE SMALL WHITE PIECES OF PLASTIC WITH FORCEPS FROM AN OPEN THYROIDECTOMY WOUND AFTER CLIP APPLICATION. NO IDENTIFIABLE DEFECTS WERE NOTED WITH THE CLIPS PRIOR TO USE. THE CLIP APPLIERS USED WERE VESOCCLUDE APPLIER 8" SM/RED TELEFLEX INC (B)(4) AND VESOCCLUDE APPLIER 8" MEDIUM TELEFLEX INC (B)(4). THE CUSTOMER STATED THAT ALL FRAGMENTS WERE RECOVERED FROM THE WOUND AND THAT THE SURGERY WAS COMPLETED. THE CUSTOMER REPORTED THAT THE PATIENT WAS DISCHARGED THE FOLLOWING DAY AND THAT THERE WAS NO SERIOUS INJURY, MEDICAL INTERVENTION, OR FOLLOW-UP CARE REQUIRED RELATED TO THE REPORTED INCIDENT. NO ADDITIONAL INFORMATION IS AVAILABLE AT THIS TIME. IT HAS BEEN DETERMINED THAT THE REPORTED EVENT COULD CAUSE OR CONTRIBUTE TO SERIOUS INJURY IF IT WERE TO OCCUR AGAIN. IN AN ABUNDANCE OF CAUTION, THIS MEDWATCH IS BEING FILED. IF ANY FURTHER RELEVANT INFORMATION IS IDENTIFIED OR OBTAINED, A SUPPLEMENTAL MEDWATCH WILL BE SUBMITTED.

    Description of Event or Problem · 0

    ACCORDING TO THE CUSTOMER, SMALL WHITE FRAGMENTS OF THE CLIP HOLDER MATERIAL HAVE BEEN COMING OFF WITH THE CLIP WHEN LOADED INTO THE CLIP APPLIERS SEVERAL TIMES. THE CUSTOMER REPORTED THAT ON (B)(6) 2025, THE SURGEON HAD TO REMOVE SMALL WHITE PIECES OF PLASTIC WITH FORCEPS FROM AN OPEN THYROIDECTOMY WOUND AFTER CLIP APPLICATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1542672 SM OR-DR. YEH PACK-LF LRO MEDLINE INDUSTRIES, LP 25DMA339 10198459164460

    Patients

    Seq Age Sex Outcome Treatment
    1 80 YR Female Other