BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CTR73 12X100 KII OPT ZTHR 6/BX

    MDR report key: 5820992 · Received July 25, 2016

    Report

    Report Number
    2027111-2016-00535
    Event Type
    Malfunction
    Date Received
    July 25, 2016
    Date of Event
    January 28, 2016
    Report Date
    December 16, 2016
    Manufacturer
    AMR
    Product Code
    GCJ
    UDI-DI
    00607915123680
    PMA / PMN Number
    K060096
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    NO PRODUCT IS BEING RETURNED FOR EVALUATION BUT LOT # IS PROVIDED. A DEVICE HISTORY REPORT IS TO BE REVIEWED BY ENGINEERING. A FOLLOW UP REPORT WILL BE SENT ONCE THE RESULTS HAVE BEEN ANALYZED. 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. THERE IS NO REPORT OF SERIOUS INJURY OR DEATH ASSOCIATED WITH THIS EVENT.

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION WAS REQUESTED FROM THE CUSTOMER AND PROVIDED. EVALUATION 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. HOWEVER, A LOT NUMBER WAS PROVIDED AND A REVIEW OF THE MANUFACTURING RECORDS INDICATES THIS LOT PASSED ALL MANUFACTURING AND QUALITY INSPECTIONS. DURING THE MANUFACTURING PROCESS, ALL TROCARS ARE THOROUGHLY INSPECTED AND TESTED FOR FUNCTIONALITY AND PERFORMANCE PRIOR TO PACKAGING. ALTHOUGH THE EXACT ROOT CAUSE OF THE EVENT COULD NOT BE CONFIRMED, THE ENGINEERING EVALUATION REVEALED THAT THE LIKELY ROOT CAUSE(S) IS DAMAGE BY AN INSTRUMENT. THE INSTRUCTIONS FOR USE (IFU) WARNS THAT "EXTRA CARE SHOULD BE USED WHEN INSERTING ANGULAR AND ASYMMETRICAL INSTRUMENTS, SUCH AS "J" HOOKS AND CLIP APPLIERS. ALL INSTRUMENTS SHOULD BE CENTERED AXIALLY WHEN INSERTED THROUGH THE SEAL TO PREVENT TEARING." APPLIED MEDICAL HAS OPENED A CORRECTIVE AND PREVENTATIVE ACTION REPORT TO FURTHER ELEVATE AND TRACK THIS INVESTIGATION AND IMPLEMENT APPROPRIATE CORRECTIVE ACTIONS TO MITIGATE THIS TYPE OF EVENT. IN ACCORDANCE TO 21 CFR 803.56, IF WE OBTAIN ADDITIONAL INFORMATION, WHICH WAS NOT KNOWN OR WAS NOT AVAILABLE WHEN THIS REPORT WAS SUBMITTED.

    Description of Event or Problem · 1

    " THIS IS A COMPLAINT FROM THE MARKET. ADMINISTRATIVE NO.(B)(4). NO DEVICE WILL BE RETURNED TO AMR AS IT WAS DISPOSED OF BY THE USER FACILITY. REPORT FROM THE SALES REP: AT THE END OF THE OPERATION, A PIECE OF THE SEPTUM WAS FOUND INSIDE THE ABDOMINAL CAVITY IN THE LAPAROSCOPIC FIELD OF VIEW. THE PIECE WAS IMMEDIATELY REMOVED FROM THE PATIENT CAVITY AND THE OPERATION WAS SUCCESSFUL WITHOUT ANY PATIENT INJURIES. THE EVENT UNIT WAS DISPOSED OF BY THE USER FACILITY INITIAL INVESTIGATION REPORT BY AOMORI OLYMPUS/ THE EVENT UNIT COULD NOT BE EVALUATED BY AOMORI OLYMPUS AS IT WAS NOT RETURNED FROM THE USER FACILITY. PLEASE ANALYZE THIS COMPLAINT PHENOMENON AND REVIEW THE DEVICE HISTORY RECORDS. ADMIN# (B)(4)." TYPE OF INTERVENTION: "UNKNOWN." PATIENT STATUS: "NO PATIENT INJURY."

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED VIA EMAIL FROM AN OLYMPUS REPRESENTATIVE ON AUGUST 01, 2016: "THE NAME OF PROCEDURE PERFORMED WAS LAPAROSCOPIC RESECTION OF THE UMBILICAL URACHUS."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    472413 CTR73 12X100 KII OPT ZTHR 6/BX GCJ GCJ AMR CTR73 1257613 00607915123680

    Patients

    Seq Age Sex Outcome Treatment
    1