BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LAHEY SCS 5-3/4 CVD

    MDR report key: 2071700 · Received February 22, 2011

    Report

    Report Number
    2523190-2011-00009
    Event Type
    Malfunction
    Date Received
    February 22, 2011
    Report Date
    February 18, 2011
    Manufacturer
    J. JAMNER SURGICAL INSTRUMENTS
    Product Code
    LRW
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    RI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE INVOLVED IN THE REPORTED INCIDENT IS NOT AVAILABLE FOR EVAL. AN INVESTIGATION HAS BEEN INITIATED BASED ON THE REPORTED INFO.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTS VIA (B)(4) THAT THE DR WAS CUTTING TISSUE DURING SURGERY AND THE SCISSORS BROKE. ON (B)(6) 2011, CUSTOMER REPORTS VIA E-MAIL THAT THE SURGEON WAS PERFORMING A GENERAL SURGERY ABDOMINAL PROCEDURE AND WHILE CUTTING SOFT TISSUE THE SCISSORS BROKE AT THE JAW SITE. THE PIECE WAS EASY TO REMOVE, X-RAY TAKEN AND NEGATIVE FOR ANYTHING LEFT IN THE WOUND. THEY REPORTED NO PT HARM, NO POTENTIAL FOR HARM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LAHEY SCS 5-3/4 CVD NA LRW J. JAMNER SURGICAL INSTRUMENTS

    Patients

    Seq Age Sex Outcome Treatment
    1 16 YR