BEUDAMED
    FDA Adverse Event Other Summary report: N

    UNIVERSAL PENDULOUS SEAL

    MDR report key: 1357435 · Received March 24, 2009

    Report

    Report Number
    2027111-2009-00025
    Event Type
    Other
    Date Received
    March 24, 2009
    Date of Event
    March 4, 2009
    Report Date
    March 31, 2009
    Manufacturer
    APPLIED MEDICAL RESOURCES
    Product Code
    HET
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    HK
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE INCIDENT DEVICE IS CURRENTLY UNDER EVALUATION. AT THE CLOSE OF THE EVALUATION, A FOLLOW-UP REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    "MARYLAND FORCEPS (A FORCEPS FROM FACILITY) WAS USED WITH THE TROCAR SYSTEM IN THE OPERATION. AFTER 10 MINUTES OF THE OPERATION, A PLASTIC RESIDUAL OF THE TROCAR WAS FOUND INSIDE THE PATIENT BODY. THE BROKEN PART OF THE TROCAR WAS PICKED UP BY THE MARYLAND FORCEPS. PATIENT'S STATUS IS NORMAL UNTIL NOW. ANOTHER TROCAR SYSTEM WAS USED TO REPLACE THE C0600 DURING THE OPERATION. HOSPITAL IS CONCERNED ABOUT THIS ISSUE SINCE IT MAY CAUSE ANOTHER UNPREDICTABLE INCIDENT IN THE FUTURE."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 UNIVERSAL PENDULOUS SEAL PENDULOUS SEAL HET APPLIED MEDICAL RESOURCES C0600 1069195

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention