BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SUREGRIP SOFT TISSUE GRASPER 9"

    MDR report key: 14756129 · Received June 17, 2022

    Report

    Report Number
    MW5110391
    Event Type
    Malfunction
    Date Received
    June 17, 2022
    Date of Event
    June 14, 2022
    Report Date
    June 15, 2022
    Manufacturer
    INNOMED, INC.
    Product Code
    HTC
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Occupation
    RISK MANAGER
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    AFTER A CASE THE SPIKE WAS NOTICED TO BE MISSING FROM THE SUREGRIP SOFT TISSUE GRASPER 9". RAD IMAGING RULED OUT RFB POST CASE. FDA SAFETY REPORT ID# (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1775117 SUREGRIP SOFT TISSUE GRASPER 9" PLIERS, SURGICAL HTC INNOMED, INC. 3645-03 (01)00840277105950

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR Female