BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    D-FLEX ANGLE TRIANG RETRACTOR 60MM 5MM

    MDR report key: 5912021 · Received August 29, 2016

    Report

    Report Number
    1038548-2016-00092
    Event Type
    Malfunction
    Date Received
    August 29, 2016
    Date of Event
    August 7, 2016
    Report Date
    October 26, 2016
    Manufacturer
    CAREFUSION, INC
    Product Code
    GCJ
    PMA / PMN Number
    K092684
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TW
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). IF FURTHER INFORMATION BECOMES AVAILABLE A FOLLOW UP MEDWATCH WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 1

    (B)(4): ONE (1) 89-6111 DEVICE WAS RETURNED FOR EVALUATION FOR STAINLESS STEEL WIRE WITH THIS DEVICE IS EXPOSED. EVALUATION OF THE DEVICE BY THE QUALITY ENGINEER AND PRODUCT ENGINEER CONFIRMED THE REPORTED ISSUE. VISUAL EXAMINATION REVEALED THAT THE CABLE HAD FRAYED AND WAS ALMOST COMPLETELY BROKEN BETWEEN THE 4TH AND 5TH SEGMENT. THESE SEGMENTS DID NOT SHOW SIGNS OF WEAR WHERE THE CABLE BROKE. ALL SEGMENTS WERE ACCOUNTED FOR AND RETAINED ON THE NITINOL WIRE (WIRE THAT HOLDS THE SEGMENTS). IT IS UNKNOWN EXACTLY HOW THE CABLE BROKE BUT THIS BREAK IS INDICATIVE OF SOME TYPE OF EXCESSIVE FORCE/ STRESS APPLIED TO THE DEVICE. THE MOST PROBABLE CAUSE IS THAT FORCE (OVERSTRESS) HAD BEEN APPLIED IN THE OPPOSITE DIRECTION OF THE BEND CAUSING THE CABLE TO WEAR PREMATURELY AND BREAK. THE BREAK IS CONSISTENT WITH MECHANICAL OVERSTRESS. NOTE THE DEVICE WAS NOT RETURNED WITH ITS PROTECTIVE STERILIZATION SLEEVE AND IT IS UNKNOWN AS TO THE USAGE OF THIS DEVICE. THIS FAILURE OF THE CABLE HAS BEEN PREVIOUSLY IDENTIFIED AND THE MOST CURRENT DESIGN UPDATE IS TO LIMIT THE TENSION OF THE DIAMOND-FLEX RETRACTOR CABLE BY LIMITING ACTUATION OF THE JACK SCREW. LIMITING TENSION IS TO PREVENT OVER-STRESSING THE CABLE WHICH COULD RESULT IN FAILURE. THIS DESIGN CHANGE WAS IMPLEMENTED TO REDUCE THE AMOUNT OF COMPLAINTS COMING FROM OVERSTRESSING THE CABLE. OVERSTRESSING THE DEVICE CAN STILL OCCUR WHEN ENOUGH FORCE AND STRESS HAS BEEN APPLIED TO THE DEVICE IN THE SEGMENTED AREA WHICH CAN CAUSE CABLES TO BREAK. A REVIEW OF THE DEVICE HISTORY RECORD DID NOT REVEAL ANY NON-CONFORMANCES. THE DEVICE PASSED ALL ACCEPTANCE CRITERIA FOR RELEASE. CONCLUSION: THE DEVICE CABLE BROKE AND FRAYED. THIS BREAK IS INDICATIVE OF SOME TYPE OF EXCESSIVE FORCE/ STRESS APPLIED TO THE DEVICE. IT IS UNKNOWN EXACTLY HOW THE CABLE BROKE BUT THE MOST PROBABLE CAUSE IS THAT FORCE (OVERSTRESS) HAD BEEN APPLIED IN THE OPPOSITE DIRECTION OF THE BEND CAUSING THE CABLE TO WEAR PREMATURELY AND BREAK. THE BREAK IS CONSISTENT WITH MECHANICAL OVERSTRESS. IT HAS BEEN RECOMMENDED TO REVIEW THE PRODUCTS INSTRUCTIONS FOR USE, IFU 26-2904 REV C, PARTICULARLY THE CAUTION, INSPECTION / MAINTENANCE, INSERTION AND REMOVAL SECTIONS. (B)(4) WILL CONTINUE TO TREND AND MONITOR THIS REPORTED ISSUE AND FOR THIS PRODUCT FAMILY. INITIAL REPORTED THE LOT NUMBER TO BE 876203.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THE STAINLESS STEEL WIRE WITH THIS DEVICE WAS EXPOSED. THE ISSUE WAS DISCOVERED BEFORE THE PROCEDURE AND THE DEVICE WAS EXCHANGED, THE PRODUCT WAS NOT USED ON THE PATIENT, THE PROCEDURE WAS COMPLETED AS PLANNED WITH NO PATIENT INJURY AND MEDICAL INTERVENTION REQUIRED, AND NO USER HARM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    564198 D-FLEX ANGLE TRIANG RETRACTOR 60MM 5MM LAPAROSCOPE, GENERAL & PLASTIC SURGERY GCJ CAREFUSION, INC 89-6111 876203 J15

    Patients

    Seq Age Sex Outcome Treatment
    1