BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HANDSWITCH PENCIL W/ HOLSTER

    MDR report key: 1003731 · Received February 20, 2008

    Report

    Report Number
    1717344-2008-00055
    Event Type
    Malfunction
    Date Received
    February 20, 2008
    Date of Event
    January 10, 2008
    Report Date
    January 22, 2008
    Manufacturer
    COVIDIEN (VALLEYLAB)
    Product Code
    GEI
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CT, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    THE PENCIL WAS TESTED AND MET SPECIFICATION. SPECIFICALLY, TESTING FOUND NO EVIDENCE OF THE BUTTON STICKING ON. THE GENERATOR WAS ALSO RETURNED AND FUNCTIONED TO SPECIFICATION. SOME PHYSICAL DAMAGE WAS FOUND WITH GENERATOR BUT DID NOT EFFECT THE PERFORMANCE OF THE GENERATOR DURING THE EVALUATION. THE GENERATOR AND INCIDENT PENCIL WERE TESTED TOGETHER IN EVERY MODE AND AT ALL POWER LEVELS AND WAS FOUND TO FUNCTION TO SPECIFICATION. THE GENERATOR IS OBSOLETE AND NO LONGER SUPPORTED BY COVIDIEN LP SINCE JULY OF 2005, SO NO REPAIRS WERE DONE. A LETTER WITH THE RESULTS OF OUR EVALUATION, SPECIFYING THE DAMAGE FOUND, WAS SENT TO THE CUSTOMER.

    Description of Event or Problem · 1

    THE REPORT STATED THAT DURING A TAH SURGERY, THE PENCIL HAD BEEN USED AT THE BEGINNING OF THE PROCEDURE. IT WAS SET ASIDE IN A NON-CONDUCTIVE PLASTIC WELL FOR APPROXIMATELY 45 MINUTES. WHEN IT WAS PULLED FROM THE WELL, THE BLADE TIP HAD A QUICK FLAME IGNITION AND THEN WENT OUT. THERE WAS A CUT TONE FROM THE GENERATOR AND THEY REPORTED THAT SWITCH ON THE PENCIL WAS STUCK ON. THEY REMOVED IT FROM THE SURGICAL FIELD AND USED ANOTHER PENCIL TO COMPLETE THE PROCEDURE. THERE WAS NO PATIENT IMPACT. THE BIOMEDICAL ENGINEER AT THE SITE TRIED TO REPLICATE THE INCIDENT, BUT WAS UNABLE. BY THE TIME HE GOT THE PENCIL, THERE WAS NO EVIDENCE OF ANY STUCK BUTTON ON THE PENCIL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HANDSWITCH PENCIL W/ HOLSTER ELECTROSURGICAL ACCESSORY GEI COVIDIEN (VALLEYLAB) UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK FORCE28PCH-ELECTROSURGICAL GENERATOR