BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    D-FLEX CIRCULAR RETRACTOR 40MM ANG 5MM

    MDR report key: 3805761 · Received May 12, 2014

    Report

    Report Number
    1038548-2014-00039
    Event Type
    Malfunction
    Date Received
    May 12, 2014
    Date of Event
    April 1, 2014
    Report Date
    May 12, 2014
    Manufacturer
    CAREFUSION
    Product Code
    GCJ
    PMA / PMN Number
    K092684
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). SHOULD THE INSTRUMENT BECOME AVAILABLE FOR EVALUATION, A FOLLOW-UP EMDR WILL BE SENT.

    Additional Manufacturer Narrative · 1

    (B)(4: )ONE (1) 89-6114 DEVICE WAS RECEIVED FOR EVALUATION FOR THE DIAMOND FLEX CIRCULAR RETRACTOR 40MM 45 DEGREE WIRE WAS CUT AND THE PARTS (SEGMENTS) WERE SEPARATED IN A PATIENT BODY. UPON RECEIPT OF THE DEVICE, THE DEVICE WAS VISUALLY EXAMINED BY THE PRODUCT ENGINEER AND QUALITY ENGINEER. IT WAS OBSERVED THAT THE DEVICE WAS WORN AND THE ONLY ETCHING FOUND ON THE DEVICE RESEMBLING A LOT NUMBER WAS E99AAAA0303 WHICH IS NOT PART OF NEITHER PREVIOUS NOR CURRENT CAREFUSION LOT NUMBERING SYSTEM. FROM THIS, IT IS ASSUMED THAT THE ¿99¿ CONTAINED IN THE LOT NUMBER IS REPRESENTATIVE OF THE YEAR OF MANUFACTURE (1999), WHICH WOULD SUGGEST THE DEVICE IS APPROXIMATELY 15 YEARS OLD (WHICH IS CONSISTENT WITH THE WORN CONDITION OF THE RETURNED DEVICE). IT WAS ALSO OBSERVED THAT THE DEVICES CABLE WAS SNAPPED AND NITINOL WIRE WAS TOTALLY BROKEN. THE HANDLE WAS VERY WORN AND FADED (GREY WHITE INSTEAD OF BLACK). THE SEGMENTS WERE LOOSELY HANGING AND STILL ON THE CUT WIRE. THE SEGMENTS WERE COUNTED AND CONFIRMED TO BE 23 SEGMENTS (WHICH YOU HAD CONFIRMED TO BE REMOVED FROM THE PATIENT) WHICH WOULD ALIGN WITH THE AMOUNT OF THE SEGMENTS USED WHEN THE DEVICE WAS MANUFACTURED IN 1999. SINCE THIS WAS A PURCHASED PRODUCT BACK IN 1999, THE DEVICE WAS FORWARDED TO THE MANUFACTURER FOR THE EVALUATION. THE EVALUATION BY THE MANUFACTURER REVEALED THAT THE APPEARANCE OF THE HANDLE TO BE WORN SUGGESTING THAT THE DEVICE HAS BEEN SUBJECTED TO EXTREME USE. THE LIP SEAL AT THE END OF THE DEVICE WAS ALSO OBSERVED TO BE MISSING, WHICH IS LIKELY A RESULT OF AN EXCESSIVE LOAD BEING APPLIED WITH THE LIKELY CAUSE OF THE FAILURE BEING A RESULT OF EXCESSIVE WEAR AND TEAR OVER TIME. THE EVALUATION OF THE DEVICE CONCLUDED THAT THE ROOT CAUSE WAS EXCESSIVE USE OF THE DEVICE BEYOND ITS INTENDED USE. ADDITIONAL INFORMATION RECEIVED ON 24JUN2014, STATED THAT THERE WAS A 24TH SEGMENT FOUND AFTER AN ADDITIONAL X-RAY TAKEN ON THE PATIENT AFTER THE INCIDENT, WHICH WAS REMOVED BY ENDOSCOPY. AS STATED IN THE MANUFACTURER¿S INVESTIGATION, IT WAS OBSERVED THAT THE LIP SEAL AT THE END OF THE SHAFT WAS BROKEN/MISSING. IT IS POSSIBLE THAT THIS HAD BEEN WHAT WAS REFERENCED AS THE ADDITIONAL SEGMENT SINCE IT WAS THE BROKEN PIECE (LIP SEAL) THAT WAS FOUND TO BE MISSING FROM THE END OF THE SHAFT.

    Description of Event or Problem · 1

    BROKEN PER AN EMAIL RECEIVED FROM THE (B)(6) CAREFUSION QRA MANAGER, A CALL WAS RECEIVED AND REPORTED THE FOLLOWING. " NITION RECEIVED A REPORT VERBALLY FROM A HOSPITAL ABOUT DIAMOND FLEX CIRCULAR RETRACTOR 40MM 45 DEGREE (ITEM #: 89-6114). DURING AN OPERATION, A WIRE WAS CUT AND THE PARTS (SEGMENTS) WERE SEPARATED IN BITS AND PIECES IN A PATIENT BODY.  DOCTOR REMOVED 23 PIECES, BUT IT SEEMS THAT THE REMAINING PARTS ARE STILL IN THE PATIENT BODY FROM X-RAY": ADDITIONAL INFORMATION RECEIVED FROM THE CUSTOMER (B)(4) 2014. IT WAS REPORTED THAT THE "ACCIDENT DID NOT CAUSE SERIOUS HEALTH HAZARD".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    284009 D-FLEX CIRCULAR RETRACTOR 40MM ANG 5MM LAPAROSCOPE, GENERAL & PLASTIC SURGERY GCJ CAREFUSION 89-6114 E99AAAA0303

    Patients

    Seq Age Sex Outcome Treatment
    1 Other| R