BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STEVENS TENOTOMY SCISSORS CVD 4.5IN

    MDR report key: 6316007 · Received February 9, 2017

    Report

    Report Number
    1423507-2017-00083
    Event Type
    Malfunction
    Date Received
    February 9, 2017
    Date of Event
    January 12, 2017
    Report Date
    February 9, 2017
    Manufacturer
    CAREFUSION, INC
    Product Code
    GEN
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AR, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CFN-2017-124;THE COMPLAINT IS FDA MDR REPORTABLE. (B)(4) IS THE IMPORTER OF RECORD AND DOES NOT OWN THE DESIGN, SPECIFICATION, OR REGULATORY PATHWAY FOR THIS DEVICE. HOWEVER, EVEN THOUGH THIS IS A PRIVATE LABEL PRODUCT (1P), THE EVENT IS MDR REPORTABLE PER QPL-8.2.1A (PRODUCT COMPLAINT MANAGEMENT) SINCE THERE WAS THE POTENTIAL FOR SERIOUS INJURY AND X-RAY TAKEN. IF ADDITIONAL INFORMATION IS MADE AVAILABLE, A FOLLOW UP WILL BE SUBMITTED.

    Description of Event or Problem · 1

    MEDICAL SPECIALTIES - SCREW FELL OUT. SALES REPRESENTATIVE STATED INSTRUMENTS OP5740 AND OP5693 ORDERED EARLY AUGUST 2016 AND WERE USED IN THEIR FIRST CASE AROUND OCTOBER 2016 AS THIS IS A BRAND NEW HOSPITAL THAT OPENED MID-SEPTEMBER. BOTH SCISSORS WERE USED DURING A FOOT CASE AND BOTH BROKE DURING THE SAME CASE. IN BOTH CASES THE SCREWS FELL OUT OF THE SCISSOR AS SEEN IN THE PICTURE. ALTHOUGH THEY COULD NOT FIND THE SCREWS THEY DID AN X-RAY AND THE SCREWS DID NOT FALL INTO THE PATIENT THEREFORE NO PATIENT WAS HARMED. BOTH SCISSORS WERE NOT USED TO CUT BONE OF ANY TYPE DURING THIS PROCEDURE ONLY TISSUE. INSTRUMENTS HAVE NOT BEEN SHARPENED NOR HAVE THEY BEEN SENT IN FOR REPAIR YET. ALL OF THE OTHER SCISSORS IN THE OTHER FOOT SETS HAVE BEEN CHECKED AND THE SCREWS DID NOT SEEM TO BE LOOSE. ALTHOUGH I JUST FOUND THIS OUT TODAY I WAS TOLD TODAY THAT LAST MONTH 2- CH5674-001 SCISSORS DID ALSO HAVE SCREWS LOOSE. THE CUSTOMER SENT THEM TO IMS FOR REPAIR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    96458 STEVENS TENOTOMY SCISSORS CVD 4.5IN STEVENS TENOTOMY SCISSORS GEN CAREFUSION, INC OP5693 XRDX06

    Patients

    Seq Age Sex Outcome Treatment
    1 Other