BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SELECTOR 24KHZ NEURO SHORT HANDPIECE

    MDR report key: 5836651 · Received August 1, 2016

    Report

    Report Number
    3006697299-2016-00162
    Event Type
    Malfunction
    Date Received
    August 1, 2016
    Report Date
    July 12, 2016
    Manufacturer
    INTEGRA LIFESCIENCES(IRELAND)
    Product Code
    LFL
    PMA / PMN Number
    K021989
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    INTEGRA HAS COMPLETED THEIR INTERNAL INVESTIGATION ON 08/23/2016. THE INVESTIGATION INCLUDED: METHODS: -EVALUATION OF ACTUAL DEVICE. -REVIEW OF DEVICE HISTORY RECORDS. -REVIEW OF COMPLAINT HISTORY. RESULTS: EVALUATION OF DEVICE: DURING INVESTIGATION IT WAS OBSERVED THAT THE HANDPIECE WAS GETTING HOT DUE TO INTERMITTENT POWER, DUE TO FAULTY HANDLE ASSEMBLY. AS PART OF THE REPAIR, THE HANDLE ASSEMBLY WAS REPLACED (NEW SN: (B)(4)) AND THE SELECTOR HANDPIECE WAS FUNCTIONALLY TESTED TO SPECIFICATIONS PRIOR BEEN RETURNED TO CUSTOMER. DHR REVIEW WAS COMPLETED FOR SELECTOR HANDPIECE 1523000M7 SERIAL NUMBER (B)(4), TIP NUMBER FLK, WORK ORDER (B)(4), MANUFACTURED IN (B)(4), TO IDENTIFY ANY RECORDED ANOMALIES THAT COULD BE ASSOCIATED TO THE COMPLAINT INCIDENT. DATE OF MANUFACTURE: JAN-2010. NO NON-CONFORMANCE REPORTS WERE RAISED DURING THE MANUFACTURING PROCESS FOR THIS HANDPIECE. THE DHR REVIEW HAS BEEN DEEMED SATISFACTORY. A MINIMUM OF 12 MONTHS¿ REVIEW WAS COMPLETED IN COMPLAINT SYSTEM FOR 1523000M7 SELECTOR HANDPIECE USING THE FOLLOWING KEYWORD ¿OVERHEATING¿ AND A ROOT CAUSE ¿FAULTY HANDLE ASSEMBLY¿ IN THE SEARCH CRITERIA. THIS REVIEW ENCOMPASSED FROM DATES 15-JUL-2015 TO 22-AUG-2016. A TOTAL 5 COMPLAINTS CONTAINED THE SEARCH CRITERIA. THE FAILURE ANALYSIS INVESTIGATION HAS CONCLUDED THE CAUSE OF THE HANDPIECE OVERHEATING WAS DUE TO FAULTY HANDLE ASSEMBLY.

    Description of Event or Problem · 1

    OVERHEATING OF THE DEVICE WAS REPORTED. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    490592 SELECTOR 24KHZ NEURO SHORT HANDPIECE N/A LFL INTEGRA LIFESCIENCES(IRELAND)

    Patients

    Seq Age Sex Outcome Treatment
    1