BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SEALING CAP

    MDR report key: 1725474 · Received June 9, 2010

    Report

    Report Number
    1418479-2010-00013
    Event Type
    Malfunction
    Date Received
    June 9, 2010
    Date of Event
    May 19, 2010
    Report Date
    June 9, 2010
    Manufacturer
    RICHARD WOLF MEDICAL INSTRUMENTS
    Product Code
    EIE
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE HAS NOT BEEN RETURNED AS YET FOR INVESTIGATION. UPON RECEIPT OF THE DEVICE WE WILL INVESTIGATE AND SEND A REPORT TO FDA.

    Description of Event or Problem · 1

    DURING A LAPAROSCOPIC EXAM WITH CYSTECTOMY AND LYSIS OF ADHESION, A SLIVER OF THE SEALING CAP CAME OFF AND WAS RETRIEVED. AN INCIDENT REPORT WAS MADE. THERE WAS NO PATIENT CONSEQUENCE. PATIENT WAS DISCHARGED (B)(6) 2010.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SEALING CAP SEALING CAP EIE RICHARD WOLF MEDICAL INSTRUMENTS 89.02BL

    Patients

    Seq Age Sex Outcome Treatment
    1