BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SEE SHARP

    MDR report key: 12384908 · Received August 27, 2021

    Report

    Report Number
    MW5103570
    Event Type
    Malfunction
    Date Received
    August 27, 2021
    Report Date
    August 25, 2021
    Manufacturer
    XODUS MEDICAL, INC.
    Product Code
    GCJ
    UDI-DI
    00787551037029
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    DURING LAPAROSCOPIC CASE, BLUE, PLASTIC PART OF TAMPON PORTION OF THE SEE SHARP (REF 30977) WAS SCRAPED UPON ENTRY INTO TROCAR. THE PLASTIC SCRAPING ACTUALLY CAME OFF AND ONTO THE FIELD. FDA SAFETY REPORT ID # (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1277890 SEE SHARP LAPAROSCOPE, GENERAL & PLASTIC SURGERY GCJ XODUS MEDICAL, INC. 21JUL26 00787551037029

    Patients

    Seq Age Sex Outcome Treatment
    1