BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HARMONIC SCALPEL LAPAROSONIC COAGULATING SHEARS

    MDR report key: 82131 · Received February 19, 1997

    Report

    Report Number
    1527736-1997-00164
    Event Type
    Malfunction
    Date Received
    February 19, 1997
    Date of Event
    January 17, 1997
    Report Date
    February 19, 1997
    Manufacturer
    EES-SMITHFIELD
    Product Code
    KNS
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    H6; CODE 100/400: BLADE FAILED/SATUTATION VOLTAGE. BASED ON THE INQUIRY INFO RECEIVED, THE VISUAL AND FUNCTIONAL TESTING, IT WAS FOUND THAT THE LCS BLADE DID NOT MEET SPECIFICATIONS. NO CONCLUSION COULD BE REACHED AS TO THE LCS DID NOT COAGULATE PROPERLY. THE MFG SITE HAS BEEN MADE AWARE OF THIS INCIDENT.

    Description of Event or Problem · 1

    DURING A LAPAROSCOPIC NISSEN FUNDOPLICATION THE LCS15 DID NOT COAGULATE PROPERLY. ANOTHER LCS15 WAS USED TO COMPLETE THE CASE. THERE WAS NO CONSEQUENCE TO THE PT. CLINICAL FOLLOW UP: 1/28/97 1530 MESSAGE AND 800 NUMBER LEFT FOR SURGEON TO CALL BACK. 1/29/97 1335 SURGEON RESPONDED AND STATED WHEN THE DEVICE WAS PUT TOGETHER IT MADE A LOUD "HISSING" SOUND. HE TRIED USING THE DEVICE ON TISSUE AND THE HISSING SOUND CONTINUED. THE DEVICE DID NOT WORK WELL ON THE TISSUE. HE STATED THAT AT THE BEGINNING OF THE CASE THE SURGICAL TECH HAD A DIFFICULT TIME REMOVING THE ALIGNMENT PIN AFTER ASSEMBLING THE DEVICE. HE WAS ABLE TO REMOVE THE ALIGNMENT PIN BUT IT WAS DIFFICULT.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Other