BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    A0803, 86MM INSERT S/T 10/BG

    MDR report key: 5776829 · Received July 7, 2016

    Report

    Report Number
    2027111-2016-00495
    Event Type
    Malfunction
    Date Received
    July 7, 2016
    Date of Event
    March 18, 2016
    Report Date
    May 3, 2017
    Manufacturer
    AMR
    Product Code
    DXC
    UDI-DI
    00607915113391
    PMA / PMN Number
    K883790
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE INCIDENT DEVICE IS ANTICIPATED TO RETURN. A FOLLOW-UP REPORT WILL BE PROVIDED UPON COMPLETION OF INVESTIGATION. IN ACCORDANCE TO 21 CFR 803.56, IF WE OBTAIN ADDITIONAL INFORMATION, WHICH WAS NOT KNOWN OR WAS NOT AVAILABLE WHEN THE INITIAL REPORT WAS SUBMITTED, THEN THE SUPPLEMENTAL REPORT WILL BE SUBMITTED TO THE FDA.

    Additional Manufacturer Narrative · 1

    INVESTIGATION SUMMARY: THE EVENT UNIT WAS NOT RETURNED FOR EVALUATION. IN THE ABSENCE OF THE SUBJECT DEVICE, IT IS DIFFICULT TO DETERMINE THE ROOT CAUSE OF THE EVENT. ALTHOUGH THE ROOT CAUSE OF THE EVENT COULD NOT BE DETERMINED, APPLIED MEDICAL WILL CONTINUE TO MONITOR ITS VIGILANCE SYSTEM FOR TRENDS AND TAKE APPROPRIATE ACTIONS AS NECESSARY.

    Description of Event or Problem · 1

    DISCOVERED PRIOR TO SURGERY - "INSERTS ARE NOT STAYING ON THE CLAMPS. MEDLINE COMPLAINT #: (B)(4), MEDLINE PART #: 05945." FROM MEDLINE: "WE WERE NOTIFIED OF A COMPLAINT FROM A CUSTOMER STATING THAT THE INSERTS ARE FALLING OF THE FOGARTY CLAMPS. THE SAMPLES WERE RECEIVED FOR INVESTIGATION AND WITHOUT THE CLAMPS THE REPORTED CONCERN COULD NOT BE CONFIRMED. THE RETURNED SAMPLES WERE MEASURED AND COMPARED TO THE SAMPLES THAT WERE PULLED FROM OUR INVENTORY. BOTH SETS CONTAIN THE SAME MEASUREMENT. WE WOULD LIKE YOUR HELP TO DETERMINE IF THE SAMPLES ARE TO YOUR SPECIFICATIONS. IF YOU WOULD LIKE THE SAMPLES RETURN FOR INVESTIGATION PLEASE PROVIDE A CALL TAG. PLEASE REFERENCE BELOW COMPLAINT NUMBER IN FUTURE COMMUNICATION." ADDITIONAL INFORMATION RECEIVED JUNE 7, 2016: "Q. CAN YOU PLEASE PROVIDE US WITH THE CUSTOMER INFORMATION? A. UNFORTUNATELY, THAT IS PROPRIETARY INFORMATION. Q. PLEASE CONFIRM THE QUANTITY INVOLVED. WHEN YOU SAY ?BOTH SETS,? DO YOU MEAN 4 TOTAL? A. THERE IS A TOTAL OF 4 TWO THAT THE CUSTOMER RETURNED AND TWO THAT WE PULLED FROM OUR STOCK TO COMPARE THE MEASUREMENTS. Q. PLEASE CONFIRM THE DATE THAT THE INCIDENT OCCURRED. A. IT WAS REPORTED ON (B)(6) 2016. Q. WHEN WAS THE INCIDENT DETECTED? WERE THE INSERTS BEING USED IN A PATIENT AT THE TIME? A. THE INCIDENT HAPPEN PRIOR TO PATIENT USE. Q. IF IT WAS DURING A PROCEDURE, WHAT PROCEDURE WAS BEING PERFORMED? A. N/A. Q. DID THE SURGEON EXPERIENCE LOSS OF OCCLUSION DUE TO THE DETACHMENT? A. PRIOR TO SURGERY. Q. WAS THERE ANY DAMAGE TO THE VESSEL? A. NO DAMAGE. Q. WHAT TYPE OF INTERVENTION WAS REQUIRED? A. REPLACED THE INSERTS WITH STERILE VERSIONS OFF THEIR SHELFS. Q. WERE THE INSERTS ABLE TO BE RETRIEVED FROM THE PATIENT? A. PRIOR TO SURGERY. Q. PLEASE PROVIDE THE PATIENT STATUS. A. NO PATIENT INJURY."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    429010 A0803, 86MM INSERT S/T 10/BG DXC DXC AMR A0803 1227412 00607915113391

    Patients

    Seq Age Sex Outcome Treatment
    1