BEUDAMED
    FDA Adverse Event Other Summary report: N

    25CM PKS SEAL, OPEN FORCEPS, CURVED JAW

    MDR report key: 1669450 · Received April 13, 2010

    Report

    Report Number
    2183680-2010-00018
    Event Type
    Other
    Date Received
    April 13, 2010
    Date of Event
    March 23, 2010
    Report Date
    April 13, 2010
    Manufacturer
    GYRUS MEDICAL, INC.
    Product Code
    GEI
    PMA / PMN Number
    K024286
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    AT THE TIME OF THIS REPORT, MULTIPLE ATTEMPTS TO OBTAIN FURTHER INFORMATION FROM THE HOSPITAL HAVE BEEN UNSUCCESSFUL, AND THE DEVICE HAS NOT YET BEEN RETURNED FOR EVALUATION. AS A RESULT, A DETERMINATION CANNOT BE MADE AT THIS TIME. IF FURTHER INFORMATION BECOMES AVAILABLE, GYRUS ACMI WILL CONTINUE THE INVESTIGATION AND UPDATE THE AGENCY ACCORDINGLY.

    Description of Event or Problem · 1

    A VAGINAL HYSTERECTOMY WAS PERFORMED ON (B)(6) 2010. THE PT RETURNED FOR A POST OP APPOINTMENT 15 DAYS LATER, WHERE THE SURGEON DISCOVERED THAT THERE WAS VAGINAL BLEEDING. THE PT WAS READMITTED TO THE OPERATING ROOM WHERE IT WAS DETERMINED LAPAROSCOPICALLY THAT THE VAGINAL CUFF WAS BLEEDING. THE BLEEDING WAS CONTROLLED WITH SUTURES. SEVERAL ATTEMPTS HAVE BEEN MADE TO DISCOVER THE PT'S CONDITION, TO NO AVAIL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 25CM PKS SEAL, OPEN FORCEPS, CURVED JAW PKS SEAL OPEN FORCEPS, CURVED JAW, 25CM GEI GYRUS MEDICAL, INC. 3103PK 147954AC

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention