BEUDAMED
    FDA Adverse Event Summary report: N

    SCHURE LOC XPS ARM POSITIONER

    MDR report key: 6090787 · Received November 9, 2016

    Report

    Report Number
    1043572-2016-00088
    Date Received
    November 9, 2016
    Date of Event
    August 15, 2016
    Report Date
    November 9, 2016
    Manufacturer
    STERIS CORPORATION - MONTGOMERY
    Product Code
    FSE
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE SCHURE LOC ARM ACCESSORY IS NOT MANUFACTURED BY STERIS CORPORATION. THIS PRODUCT IS USED AS AN ACCESSORY WITH A STERIS SURGICAL TABLE. STERIS HAS PROVIDED SCHUERCH CORPORATION, THE MANUFACTURER OF THE SCHURE LOC ARM ACCESSORY, WITH THE INFORMATION REGARDING THE REPORTED EVENT. THIS FOLLOW UP REPORT IS BEING SENT AS STERIS IS THE DISTRIBUTOR OF THE SCHURE LOC ARM ACCESSORY AND USER FACILITY PERSONNEL CONTACTED STERIS, NOT SCHUERCH CORPORATION, FOLLOWING THE REPORTED EVENT.

    Additional Manufacturer Narrative · 1

    THE USER FACILITY REPORTED THAT THEIR SCHURE LOC ARM ACCESSORY TO THEIR SURGICAL TABLE WAS SLIPPING OUT OF THE LOCKED POSITION DURING A PATIENT PROCEDURE. NO PROCEDURE DELAYS OR CANCELLATIONS WERE REPORTED. THE SCHURE LOC ARM IS AN INTEROPERATIVE LIMB POSITIONER WHICH PROVIDES THE ORTHOPEDIC TEAM WITH A SECURE HOLD OF THEIR PATIENT'S EXTREMITIES FOR SHOULDER SURGERIES. THE SCHURE LOC ARM IS NOT MANUFACTURED BY STERIS. THE MANUFACTURER OF THE SCHURE LOC ARM WAS NOTIFIED OF THE REPORTED EVENT. THE SCHURE LOC ARM SUBJECT OF THE REPORTED EVENT IS BEING RETURNED TO THE MANUFACTURER FOR EVALUATION. THE INSTRUCTIONS FOR USE STATES: WARNING! RISK OF INJURY DUE TO UNINTENDED MOVEMENTS DOWNWARDS. WHEN SQUEEZING THE TRIGGER, THE SWIVEL JOINTS ARE RELEASED AND THE SCHURE LOC XPS CAN BE MOVED. DUE TO ITS OWN WEIGHT AND THE WEIGHT OF THE PATIENT IT WILL FALL DOWNWARDS. BEFORE SQUEEZING THE TRIGGER, FIRMLY HOLD THE SCHURE LOC WITH BOTH HANDS. AFTER EVERY ADJUSTMENT PROCESS, ENSURE THAT THE TRIGGER IS RELEASED AND LOCKS THE SCHURE LOC INTO PLACE. CHECK THAT NO FOREIGN BODIES ARE PINCHED. THE STERIS ACCOUNT MANAGER WILL COMPLETE IN-SERVICE TRAINING ON THE PROPER USE AND OPERATION OF THE DEVICE ONCE THE FACILITY RECEIVES A REPLACEMENT PRODUCT.

    Description of Event or Problem · 1

    THE USER FACILITY REPORTED THAT THEIR SCHURE LOC ARM ACCESSORY WAS NOT OPERATING PROPERLY DURING A PATIENT PROCEDURE. NO REPORT OF INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    739695 SCHURE LOC XPS ARM POSITIONER TABLE ACCESSORY FSE STERIS CORPORATION - MONTGOMERY

    Patients

    Seq Age Sex Outcome Treatment
    1