BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SUREGRIP SOFT TISSUE GRASPER 9"

    MDR report key: 14935174 · Received July 6, 2022

    Report

    Report Number
    1833053-2022-00003
    Event Type
    Malfunction
    Date Received
    July 6, 2022
    Date of Event
    June 13, 2022
    Report Date
    August 30, 2022
    Manufacturer
    INNOMED, INC.
    Product Code
    HTC
    UDI-DI
    00840277105950
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    RISK MANAGER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    INNOMED, INC. WAS ALERTED OF THE DESCRIBED EVENT VIA MAIL ON JUNE 28, 2022. NO INFORMATION WAS LISTED ON THE REPORT REGARDING THE INITIAL REPORTER, OR THE USER FACILITY, THEREFORE INNOMED WAS UNABLE TO REQUEST AND RECEIVE THE AFFECTED DEVICE TO PERFORM AN EVALUATION. NO INVESTIGATION COULD BE CONDUCTED. A SURVEY OF THE INTERNAL COMPLAINTS DATABASE IDENTIFIED THAT THE DESCRIBED EVENT ALSO OCCURRED WITH TWO SIMILAR PARTS (3645-01 AND 3645-02). AFTER AN INVESTIGATION WAS PERFORMED IN EACH CASE, A ROOT CAUSE WAS DETERMINED AND CORRECTIVE AND PREVENTIVE MEASURES WERE IMPLEMENTED. INNOMED WILL CONTINUE TO TREND THE AFFECTED AND SIMILAR PARTS TO DETERMINE IF ADDITIONAL CORRECTIVE AND PREVENTIVE MEASURES ARE REQUIRED.

    Description of Event or Problem · 0

    SPD NOTICED THAT THE SUREGRIP TISSUE GRASPER 9" WAS MISSING THE SPIKE.

    Description of Event or Problem · 0

    SPD NOTICED THAT "THE" SURE GRIP TISSUE GRASPER 9" WAS MISSING THE SPIKE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2371941 SUREGRIP SOFT TISSUE GRASPER 9" PLIERS, PRODUCT CODE: HTC HTC INNOMED, INC. 3645-03 00840277105950

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown