BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ASIM TENOTOMY SCISSORS

    MDR report key: 1748441 · Received June 30, 2010

    Report

    Report Number
    MW5016579
    Event Type
    Injury
    Date Received
    June 30, 2010
    Date of Event
    June 29, 2010
    Report Date
    June 30, 2010
    Manufacturer
    ASSI - ACCURATE SURGICAL & SCIENTIFIC INSTRUMENTS CORP
    Product Code
    LRW
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    SC, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    TENOTOMY SCISSORS TIP BROKE OFF INTO PT'S WOUND WHEN BEING USED. OEC USED TO LOCATE AND RETRIEVE BROKEN PIECE. VERIFIED REMOVAL BY VIDEO VISUALIZATION. DATES OF USE: 2 HOURS APPROX; (B)(6) 2010-(B)(6) 2010. DIAGNOSIS OR REASON FOR USE: EQUINUS CONTRACTURE, RIGHT ANKLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ASIM TENOTOMY SCISSORS TENOTOMY SCISSORS LRW ASSI - ACCURATE SURGICAL & SCIENTIFIC INSTRUMENTS CORP ASIM-12-0041 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 38 YR Disability