BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HARMONIC SCALPEL LAPAROSONIC COAGULATING SHEARS

    MDR report key: 82303 · Received February 20, 1997

    Report

    Report Number
    1222781-1997-00004
    Event Type
    Malfunction
    Date Received
    February 20, 1997
    Date of Event
    January 26, 1997
    Report Date
    February 20, 1997
    Manufacturer
    EES-SMITHFIELD
    Product Code
    KNF
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    D6; DEVICE WAS NOT RETURNED FOR EVAL.

    Description of Event or Problem · 1

    DURING AN LAPAROSCOPIC ASSISTED VAGINAL HYSTERECTOMY, THE SURGEON DID NOT FEEL HE WAS GETTING HEMOSTASIS. CAUTERY WAS USED TO COMPLETE THE CASE. NO CONSEQUENCE TO THE PT. 1/31/97 - REP REPORTED THE LCS15 BLADE WAS USED AND DID NOT COMPLETE GOOD HEMOSTASIS. THE SURGEON PULLED DEVICE AND USED CAUTERY TO COMPLETE THE CASE. CLINICAL FOLLOW UP: 1/31/97 1555 MESSAGE AND 800 NUMBER LEFT FOR SURGEON TO CALL BACK. 1/3/97 0950 SURGEON SAID HE WAS NOT GETTING ACCEPTABLE HEMOSTASIS. THE SURGEON IS VERY DISSATIFIED WITH THE INSTRUMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HARMONIC SCALPEL LAPAROSONIC COAGULATING SHEARS COAGULATING SHEAR KNF EES-SMITHFIELD NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Other