BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MICROFRANCE® INSTRUMENT

    MDR report key: 3971702 · Received July 31, 2014

    Report

    Report Number
    9680837-2014-00063
    Event Type
    Malfunction
    Date Received
    July 31, 2014
    Date of Event
    July 3, 2014
    Report Date
    July 7, 2014
    Manufacturer
    XOMED MICROFRANCE MFG
    Product Code
    GEI
    PMA / PMN Number
    K993655
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE PRODUCT ANALYSIS INDICATES THAT ONE OF THE JAWS IS BROKEN AT THE PROXIMAL SIDE OF THE COATED PART. AFTER DISASSEMBLY, IT APPEARS THAT THE INSTRUMENT CONTAINS SOME SURGERY RESIDUES. NO MATERIAL OR MANUFACTURING DEFECT WAS DETECTED. THE INSTRUMENT DAMAGE IS MOST LIKELY A RESULT OF EXCESSIVE CONSTRAINTS DURING USE OR REPROCESSING. (B)(4).

    Description of Event or Problem · 1

    THE FORCEPS WERE RETURNED FOR REPAIR. PREOPERATIVE, THE TIP OF ONE OF THE FORCEPS BROKE OFF. THERE WAS NO INJURY REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    447926 MICROFRANCE® INSTRUMENT ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES GEI XOMED MICROFRANCE MFG CEV134BG 121002

    Patients

    Seq Age Sex Outcome Treatment
    1