BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HYF HND SWTCH PENCL AUTOCLAVAB

    MDR report key: 8518843 · Received April 16, 2019

    Report

    Report Number
    3007305485-2019-00102
    Event Type
    Malfunction
    Date Received
    April 16, 2019
    Date of Event
    March 13, 2019
    Report Date
    April 16, 2019
    Manufacturer
    CONSOLIDATED MEDICAL EQUIPMENT
    Product Code
    GEI
    PMA / PMN Number
    K001159
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    DE, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    AN EVALUATION AND TESTING OF THE RETURNED HYFRECATOR PENCIL, 7-900-5, WHICH WAS TESTED WITH THE SAME HYFRECATOR UNIT, SERIAL # (B)(4), FOUND NO ISSUES WITH THE PENCIL. PER THE EVALUATION AND TESTING OF THE RETURNED HYFRECATOR UNIT, 7-900-115, WHICH WAS TESTED WITH THE HYFRECATOR PENCIL, THE HYFRECATOR UNIT WAS OVERDUE FOR PREVENTIVE MAINTENANCE AND FAILED HI OPEN CIRCUIT VOLTAGE TESTING. THE PREVENTIVE MAINTENANCE WAS COMPLETED ON THE HYFRECATOR UNIT. A TWO-YEAR REVIEW OF COMPLAINT HISTORY REVEALED THERE HAS BEEN A TOTAL OF TWO COMPLAINTS, REGARDING TWO DEVICES, FOR THIS DEVICE FAMILY AND FAILURE MODE. DURING THIS SAME TIME FRAME (B)(4) DEVICES HAVE BEEN MANUFACTURED AND SHIPPED WORLDWIDE. SHOULD ALL THE COMPLAINT DEVICES HAVE BEEN FOUND CONFIRMED FOR THIS REPORTED FAILURE, THE RATE OF FAILURE WOULD BE (B)(4). PER THE INSTRUCTIONS FOR USE, THE USER IS ADVISED THE FOLLOWING: WARNING: -PROLONGED USE OF THE HANDPIECE CAUSES THE ELECTRODE TO BECOME VERY HOT AND THE TIP REMAINS HOT FOR A PERIOD AFTER USE. CAUTIONS: -USE LOWEST POSSIBLE POWER SETTING ON THE HYFRECATOR 2000 ELECTROSURGICAL GENERATOR AND SHORTEST POSSIBLE ACTIVATION TIME CAPABLE OF ACHIEVING THE DESIRED SURGICAL EFFECT. INSPECTION: -THESE DEVICES SHOULD BE INSPECTED BEFORE USE. VISUALLY EXAMINE THE DEVICE FOR OBVIOUS PHYSICAL DAMAGE: - CRACKED, BROKEN OR OTHERWISE DISTORTED PLASTIC PARTS; -DAMAGE INCLUDING CUTS, PUNCTURES, NICKS, ABRASIONS, UNUSUAL LUMPS OR SIGNIFICANT DISCOLORATION. THIS ISSUE WILL CONTINUE TO BE MONITORED THROUGH THE COMPLAINT SYSTEM TO ASSURE PATIENT SAFETY.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT 7-900-5, HUF HND SWTCH PENCL AUTOCLAVAB, DEVICE WAS BEING USED DURING A SKIN TAG REMOVAL ON (B)(6) 2019 WHEN A SPARK CAME FROM THE PENCIL CAUSING THE PATIENT'S HAIR TO CATCH ON FIRE. THE FIRE WAS PUT OUT; THE PATIENT'S SCALP WAS RED FROM THE FIRE. THE PATIENT'S SCALP WAS NOT REPORTED TO BE BURNED. THERE WAS NO REPORTED INJURY TO THE PATIENT OR USER. THERE WAS NO REPORT OF MEDICAL INTERVENTION OR HOSPITALIZATION FOR THE PATIENT. THE PROCEDURE WAS NOT COMPLETED. IT IS REPORTED THAT THE PATIENT WENT TO HER HAIRSTYLIST AND FOUND THAT IT WILL TAKE 4 HAIRCUTS TO CORRECT THE DAMAGE TO HER HAIR. THIS REPORT IS BEING RAISED ON THE BASIS OF MALFUNCTION WITH POTENTIAL FOR INJURY UPON REOCCURRENCE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    312324 HYF HND SWTCH PENCL AUTOCLAVAB ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES GEI CONSOLIDATED MEDICAL EQUIPMENT

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR