BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CUTTING FORCEP

    MDR report key: 3201741 · Received June 28, 2013

    Report

    Report Number
    2183680-2013-00035
    Event Type
    Injury
    Date Received
    June 28, 2013
    Report Date
    June 5, 2013
    Manufacturer
    GYRUS MEDICAL INC.
    Product Code
    GEI
    PMA / PMN Number
    K023492
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    AT THE TIME OF THIS REPORT, MULTIPLE ATTEMPTS TO OBTAIN FURTHER INFO FROM THE HOSPITAL HAVE BEEN UNSUCCESSFUL, AND THE DEVICE HAS NOT YET BEEN RETURNED FOR EVAL. AS A RESULT, A DETERMINATION CANNOT BE MADE AT THIS TIME. IF FURTHER INFO BECOMES AVAILABLE, (B)(4) WILL CONTINUE THE INVESTIGATION. AND UPDATE THE AGENCY ACCORDINGLY.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A LAPAROSCOPIC TUBAL LIGATION THE FORCEPS BECAME STUCK ON THE TUBE. THE SURGEON HAD TO OPEN THE PT TO FINISH THE PROCEDURE AND RELEASE THE FORCEPS FROM THE TUBE. THE PROCEDURE WAS COMPLETED WITH NO INJURIES TO THE PT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    297111 CUTTING FORCEP CUTTING FORCEP GEI GYRUS MEDICAL INC. 3005 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Hospitalization| O| R