BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CTF73, 12X100 KII FIOS ZTHR 6/BX

    MDR report key: 5721520 · Received June 13, 2016

    Report

    Report Number
    2027111-2016-00446
    Event Type
    Malfunction
    Date Received
    June 13, 2016
    Date of Event
    May 17, 2016
    Report Date
    May 17, 2016
    Manufacturer
    APPLIED MEDICAL RESOURCES
    Product Code
    GCJ
    UDI-DI
    00607915123703
    PMA / PMN Number
    K041795
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GB
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION SUMMARY: THE EVENT UNIT WAS RETURNED FOR EVALUATION. UPON INSPECTION, ENGINEERING NOTED NO VISIBLE DAMAGE TO THE EXTERIOR OF THE DEVICE. ENGINEERING REMOVED THE SEAL AND NOTED NO DAMAGE TO THE DUCKBILL. THE DUCKBILL WAS REMOVED AND THE SEPTUM WAS FOUND TO BE TORN AND MISSING A PORTION. THE MISSING PORTION WAS NOT RETURNED, THEREFORE IT COULD NOT BE CONFIRMED WHETHER OR NOT IT MATCHED THE HOLE ENGINEERING IDENTIFIED IN THE SEPTUM. A REVIEW OF THE MANUFACTURING RECORDS INDICATES THIS LOT PASSED ALL MANUFACTURING AND QUALITY INSPECTIONS. ALL SEALS ARE THOROUGHLY INSPECTED AND TESTED DURING THE MANUFACTURING PROCESS. THE DAMAGE TO THE SEPTUM APPEARS TO HAVE BEEN CAUSED BY AN INSTRUMENT. THERE IS ALWAYS A POTENTIAL TO TEAR OR DISLODGE THE INTERNAL SEAL COMPONENTS WITH MULTIPLE PASSES OF INSTRUMENTS, ESPECIALLY WITH SHARP OR ANGULAR DEVICES. THE INSTRUCTIONS FOR USE (IFU) WARNS THAT, "EXTRA CARE SHOULD BE USED WHEN INSERTING ANGULAR AND ASYMMETRICAL INSTRUMENTS. ALL INSTRUMENTS SHOULD BE CENTERED AXIALLY WHEN INSERTED THROUGH THE SEAL TO PREVENT TEARING." ENGINEERING IS CURRENTLY RESEARCHING POSSIBLE DEVICE ENHANCEMENTS INTENDED TO FURTHER MINIMIZE THE POTENTIAL FOR THIS TYPE OF INCIDENT TO OCCUR. 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, THEN A SUPPLEMENTAL REPORT WILL BE SUBMITTED TO THE FDA.

    Additional Manufacturer Narrative · 1

    RA HAS RECEIVED THE INCIDENT DEVICE AND HAS BEEN ASSIGNED TO ENGINEERING FOR EVALUATION. A FOLLOW-UP REPORT WILL BE SENT 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. THERE IS NO REPORT OF SERIOUS INJURY OR DEATH ASSOCIATED WITH THIS EVENT.

    Description of Event or Problem · 1

    LAPAROSCOPIC GASTRIC BAND INSERTION - "SURGEON WAS INSERTING THE GASTRIC BAND (COUSIN BIOTECH BIORING) USING JOHAN GRASPER THROUGH THE TROCAR AND A SMALL FRAGMENT OF THE SEAL BROKE OFF AND WAS SEEN IN THE PATIENT'S ABDOMEN. SURGEON SAID HE COULD FEEL IT HAPPEN AT THE TIME AND THAT THE GRASPER AND BAND HAD GONE IN AT A SLIGHT ANGLE RATHER THAN COMPLETELY STRAIGHT. FRAGMENT WAS REMOVED FROM PATIENT AND SURGERY PROCEEDED WITHOUT FURTHER INCIDENT." PATIENT STATUS: HEALTHY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    374998 CTF73, 12X100 KII FIOS ZTHR 6/BX GCJ GCJ APPLIED MEDICAL RESOURCES CTF73 1263603 00607915123703

    Patients

    Seq Age Sex Outcome Treatment
    1