BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    REPROCESSED HARMONIC SCALPEL

    MDR report key: 1913013 · Received August 6, 2010

    Report

    Report Number
    2134070-2010-00012
    Event Type
    Malfunction
    Date Received
    August 6, 2010
    Date of Event
    July 14, 2010
    Report Date
    August 5, 2010
    Manufacturer
    STERILMED, INC.
    Product Code
    NLQ
    PMA / PMN Number
    050343
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    THE USER FACILITY REPORTED THAT THE DEVICE WAS DEFECTIVE AND THE TISSUE PAD ON THE JAW DETACHED DURING USE. THE USER FACILITY HAS STATED THAT THEY ARE UNCERTAIN AS TO WHETHER OR NOT THE TISSUE PAD WAS LEFT IN THE PT. IN THE EVENT THAT THE PAD DETACHED AND WAS LEFT INSIDE THE PT, THE PAD POSES MINIMAL RISK AS IT IS COMPRISED OF TEFLON (PTFE), WHICH IS AN INERT MATERIAL KNOWN TO BE BIOCOMPATIBLE AND MATERIAL OF CHOICE FOR IMPLANTED DEVICES. THROUGH FOLLOW-UP WITH THE USER FACILITY, IT WAS CONFIRMED THAT THERE WAS NO PT INJURY OR ANY OTHER NEGATIVE HEALTH RELATED OUTCOME RELATED TO THIS EVENT. STERILMED WILL CONTINUE TO MONITOR THIS SITUATION AND KEEP FDA APPRISED OF ANY UPDATES RELATED TO THE CONDITION OF THE PT IN THE FUTURE. THE DEVICE IN QUESTION WAS RETURNED TO STERILMED ON (B)(4)2010, FOR INVESTIGATION AND THE ABSENCE OF THE TISSUE PAD WAS CONFIRMED. IN STERILMED'S EXPERIENCE, THIS INCIDENT WAS MOST LIKELY THE RESULT OF USER ERROR WHEREBY THE DEVICE WAS ACTIVATED WITH NO TISSUE WITHIN THE JAWS. IT IS RECOMMENDED IN BOTH THE STERILMED AND OEM IFU DOCUMENTS TO KEEP THE JAWS OPEN IF THE BLADE IS ACTIVE WHILE TISSUE IS NOT BETWEEN THE BLADE AND TISSUE PAD TO AVOID DAMAGE TO THE INSTRUMENT.

    Description of Event or Problem · 1

    THE JAW PAD OF AN ULTRASONIC SCALPEL WAS REPORTED TO FALL OFF INSIDE OF A PT DURING A PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 REPROCESSED HARMONIC SCALPEL NLQ STERILMED, INC. ACE36E

    Patients

    Seq Age Sex Outcome Treatment
    1