BEUDAMED
    FDA Adverse Event Injury Summary report: N

    KIRWAN BIPOLAR FORCEPS

    MDR report key: 3766563 · Received April 11, 2014

    Report

    Report Number
    1644019-2014-00066
    Event Type
    Injury
    Date Received
    April 11, 2014
    Manufacturer
    ALCON-HOUSTON
    Product Code
    HQE
    PMA / PMN Number
    K861380
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE CUSTOMER'S COMPLAINT HISTORY WAS REVIEWED FOR THE PERIOD OF ONE YEAR; THIS IS THE FIRST COMPLAINT REPORTED FOR THIS ISSUE. THE FINISHED GOOD LOT SPECIFIC TO THIS EVENT IS NOT KNOWN; THEREFORE, LOT HISTORY AND DHR (DEVICE HISTORY RECORD) REVIEW WAS NOT POSSIBLE. THE ROOT CAUSE OF THE CUSTOMER'S COMPLAINT IS NOT KNOWN; A SAMPLE WAS NOT RETURNED FOR INVESTIGATION. NO FURTHER INFO IS EXPECTED FOR THIS CASE. (B)(4).

    Description of Event or Problem · 1

    A DOCTOR REPORTED THAT AN UNEXPECTED THERMAL BURN OCCURRED WHEN THE BIPOLAR FORCEPS WERE USED WITH ANOTHER COMPANY'S CONSOLE FOR PLASTIC SURGERY. THE FORCEPS HAD BEEN USED FOR TEN CASES INCLUDING THIS CASE. NO FURTHER INFO IS EXPECTED FOR THIS CASE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    221547 KIRWAN BIPOLAR FORCEPS FORCEPS, OPTHALMIC/UNIT, PHACOFRAGMENTATION HQE ALCON-HOUSTON 8065127501 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Other