BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    REYNOLDS SUPERCUT SCISSORS

    MDR report key: 2823643 · Received August 5, 2010

    Report

    Report Number
    2434839-2010-00001
    Event Type
    Malfunction
    Date Received
    August 5, 2010
    Manufacturer
    ACCURATE SURGICAL & SCIENTIFIC INSTRUMENTS
    Product Code
    LRW
    PMA / PMN Number
    E177542/LRW
    Report Source
    Manufacturer report
    Reporter Location
    SC, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCLUSION: BASED ON THE VISIBLE STRONG OUTSIDE DAMAGES THESE SCISSORS HAVE BEEN IMPROPER REPAIRED WHICH LEAD TO THE BREAKAGE OF THE TIP. WE WOULD LIKE TO INDICATE THAT ANY KIND OF WARRANTY CLAIM IS EXPIRED SINCE THE PRODUCT WAS REPAIRED BY A THIRD PARTY. FOR FURTHER INFO ABOUT CARE OF INSTRUMENT WE KINDLY ASK YOU TO GO TO THE WEB UNDER WWW/A-K-I.ORG CLICK AKI BROCHURES, RED BROCHURE - PROPER MAINTENANCE OF INSTRUMENTS.

    Description of Event or Problem · 1

    THE TIP OF THE SCISSORS BROKE. THERE WAS NO PT INJURY REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 REYNOLDS SUPERCUT SCISSORS SCISSORS TENOTOMY LRW ACCURATE SURGICAL & SCIENTIFIC INSTRUMENTS ASIM120641 20925683

    Patients

    Seq Age Sex Outcome Treatment
    1