BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RICHARD WOLF MEDICAL INSTRUMENT CORP

    MDR report key: 38255 · Received September 10, 1996

    Report

    Report Number
    38255
    Event Type
    Injury
    Date Received
    September 10, 1996
    Date of Event
    July 11, 1996
    Report Date
    August 1, 1996
    Manufacturer
    RICHARD WOLF MEDICAL
    Product Code
    HIH
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    THE PT UNDERWENT A LAPARSCOPIC SURGERY. SHE PRESENTED TO THE HOSP'S ER ON 7/23/96, COMPLANING OF BLEEDING AND DISCOMFORT. THE ER DR REMOVED A "COHEN CANNULA" FROM THE PT'S CERVIX. THE CANNULA HAD BEEN LEFT IN THE PT'S CERVIX UPON COMPLETION OF THE LAPAROSCOPY. REMOVAL OF THE DEVICES WAS UNDER THE DIRECTION OF THE DR'S PRIVATE SCRUB NURSE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RICHARD WOLF MEDICAL INSTRUMENT CORP "COHEN" CANNULA LARGE ACORN HIH RICHARD WOLF MEDICAL NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 25 YR Required Intervention TYPICAL LAPROSCIPIC INSTRUMENTS