BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CLAMP

    MDR report key: 7702360 · Received July 19, 2018

    Report

    Report Number
    2921578-2018-00027
    Event Type
    Injury
    Date Received
    July 19, 2018
    Date of Event
    March 7, 2017
    Report Date
    November 14, 2018
    Manufacturer
    MIZUHO ORTHOPEDIC SYSTEMS, INC.
    Product Code
    JEA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    THE MIZUHO DEVICE (REFERRED TO AS "CLAMPS") REPORTEDLY INVOLVED IN THE EVENT WAS NOT RETURNED FOR EVALUATION AND THE PICTURES PROVIDED DO NOT ALLOW FOR IDENTIFICATION. NOTE THAT INFORMATION PROVIDED IN THE MDR SUBMITTED BY THE MANUFACTURER OF THE OTHER DEVICE, T-MAX BEACH CHAIR, (1643264-2017-00147) INVOLVED IN THE EVENT STATES THE IFU INCLUDES SPECIFIC INSTRUCTIONS REGARDING CLAMPS USED WITH THEIR T-MAX CHAIR, INCLUDING A WARNING NOT TO USE OTHER MANUFACTURER'S CLAMPS.

    Description of Event or Problem · 0

    TWO MIZUHO OSI CLAMPS WERE USED TO SECURE A SMITH & NEPHEW T-MAX EXPOSURE SHOULDER POSITIONER ONTO AN OPERATING TABLE. DURING SURGERY (ARTHROSCOPIC ROTATOR CUFF REPAIR), BOTH CLAMPS BROKE AND THE PATIENT FELL OFF THE TABLE, STRIKING HIS HEAD ON THE FLOOR. THE PATIENT REPORTS SEVERE AND DEBILITATING PAIN AND COGNITIVE PROBLEMS. SEE ALSLO MDR 1643264-2017-00147

    Description of Event or Problem · 1

    TWO MIZUHO OSI CLAMPS WERE USED TO SECURE A SMITH & NEPHEW T-MAX EXPOSURE SHOULDER POSITIONER ONTO AN OPERATING TABLE. DURING SURGERY (ARTHROSCOPIC ROTATOR CUFF REPAIR), BOTH CLAMPS BROKE AND THE PATIENT FELL OFF THE TABLE, STRIKING HIS HEAD ON THE FLOOR. THE PATIENT REPORTS SEVERE AND DEBILITATING PAIN AND COGNITIVE PROBLEMS. SEE ALSO MDR 1643264-2017-00147.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    547122 CLAMP JEA MIZUHO ORTHOPEDIC SYSTEMS, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Other