BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MICROFRANCE® GENERAL/HOSPITAL INSTRUMENTS

    MDR report key: 3883414 · Received June 19, 2014

    Report

    Report Number
    9680837-2014-00050
    Event Type
    Malfunction
    Date Received
    June 19, 2014
    Date of Event
    May 23, 2014
    Report Date
    May 28, 2014
    Manufacturer
    XOMED MICROFRANCE MFG
    Product Code
    LRC
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    LOT: 201108MF. DATE MFR RECEIVED: JUNE 19, 2014. DEVICE MFG DATE: AUGUST 2011. PRODUCT EVALUATION: ANALYSIS FOUND THAT THE BLADE IS BROKEN AT THE CENTRAL SCREW LEVEL. THE BROKEN FRAGMENT HAS BEEN RECOVERED. THE OBSERVATION OF THE BREAKAGE ZONE HAS REVEALED A CORRODED AREA WHICH INDICATES THAT A PRE-EXISTING CRACK WAS PRESENT PRIOR THE BREAKAGE. NO OTHER MATERIAL DEFECT HAS BEEN OBSERVED OUTSIDE THIS CORRODED ZONE. THE INSTRUMENT HAS PROBABLY BEEN WEAKENED BY A PRE-EXISTING CRACK THAT HAS LED TO THE OBSERVED BREAKAGE DURING USE. THE CAUSE OF THE PRE-EXISTING CRACK IS PROBABLY DUE TO THE MAINTENANCE, AS THE DRYING OF THE SCISSORS IN A CLOSED POSITION OR THE USE OF NON-ADAPTED WATER. (B)(4)

    Additional Manufacturer Narrative · 1

    THIS DEVICE IS USED FOR THERAPEUTIC PURPOSES. (B)(4). PRODUCT EVALUATION: ANALYSIS NOT AVAILABLE AT THIS TIME; EVALUATION IN PROGRESS. METHOD: NO TESTING METHODS PERFORMED.

    Additional Manufacturer Narrative · 1

    IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A SEPTORHINOPLASTY CASE THE SCISSORS SNAPPED AT THE SCREW WHERE THE TWO SCISSOR PIECES ARE JOINED AND HELD TOGETHER; THE STEEL AROUND THE JOINT AREA SNAPPED. THE PHYSICIAN WAS ABLE TO OPEN A DIFFERENT PAIR OF SCISSOR AND COMPLETE THE CASE WITHOUT PATIENT IMPACT. IT WAS CONFIRMED THAT THE DEVICE DID BREAK INTO PIECES AND THE DOCTOR THREW THE TIP OF THE SCISSORS INTO THE SHARPS CONTAINER; THAT PIECE WILL NOT BE RETURNED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    360284 MICROFRANCE® GENERAL/HOSPITAL INSTRUMENTS INSTRUMENT, ENT MANUAL SURGICAL LRC XOMED MICROFRANCE MFG CP348 201108MF

    Patients

    Seq Age Sex Outcome Treatment
    1 00020 YR