BEUDAMED
    FDA Adverse Event Other Summary report: N

    PRECISION SURGICAL

    MDR report key: 1971685 · Received January 20, 2011

    Report

    Report Number
    MW5019121
    Event Type
    Other
    Date Received
    January 20, 2011
    Date of Event
    January 18, 2011
    Report Date
    January 20, 2011
    Manufacturer
    PRECISION SURGICAL
    Product Code
    LRW
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    IN, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    IN TWO SEPARATE PROCEDURAL CASES, THE METAL TIPS OF CUSTOM-MADE PRECISION SURGICAL SCISSORS BROKE OFF OF THE INSTRUMENT. ONE SET BROKE ON THE STERILE FIELD, THE OTHER RESULTED IN A TIP THAT COULD NOT BE LOCATED. DIAGNOSIS: SURGICAL SITE CLOSURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PRECISION SURGICAL SUTURE SCISSOR LRW PRECISION SURGICAL 24173 19-132614
    2 PRECISION SURGICAL SUTURE SCISSOR LRW PRECISION SURGICAL 24173 19-13314

    Patients

    Seq Age Sex Outcome Treatment
    1 Other