BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CFS22, 12X100 KII SLEEVE ADVFIX 12/BX

    MDR report key: 5774172 · Received July 6, 2016

    Report

    Report Number
    2027111-2016-00494
    Event Type
    Malfunction
    Date Received
    July 6, 2016
    Date of Event
    June 3, 2016
    Report Date
    June 7, 2016
    Manufacturer
    APPLIED MEDICAL RESOURCES
    Product Code
    GCJ
    PMA / PMN Number
    K083638
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UT, US
    Reporter Occupation
    OTHER

    Narratives

    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.

    Additional Manufacturer Narrative · 1

    INCIDENT 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 HOUSING AND NOTED FRAGMENTATION TO THE DUCKBILL. THE DUCKBILL WAS REMOVED AND THE SEPTUM WAS FOUND TO BE TORN AND MISSING A PORTION. ALL SEALS ARE THOROUGHLY INSPECTED AND TESTED 100% FOR LEAKAGE DURING THE MANUFACTURING PROCESS. THE DAMAGE TO THE SEPTUM AND DISLODGEMENT OF THE SHIELD & DUCKBILL APPEAR 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 WITH 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. THIS REPORT IS TO FOLLOW UP WITH MEDWATCH# MW5062928.

    Description of Event or Problem · 1

    ROBOTIC ASSISTED VENTRAL HERNIA REPAIR - "DURING THE CASE WHILE THE SURGICAL TECH WAS INSERTING THE MESH THROUGH OUR CFS22 THE DOUBLE DUCK BILL SEAL WAS DISLODGED AND PUSHED THROUGH THE SLEEVE AND INTO THE PATIENT. DR. (B)(6) WAS AT THE ROBOT AND NOTICED THE SEAL INSIDE THE PATIENT. THE CUSTOMER DID NOT SAVE THE PACKAGING SO THESE ARE THE REMAINING LOT NUMBERS THAT THEY HAVE. 1237986, 1237515, 1240711, 1232066, 1259880." PATIENT STATUS- UNKNOWN.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED VIA MEDWATCH MW5062928 VIA EMAIL 12 JUNE 2016: "TROCAR WAS USED TO ASSIST WITH ROBOTIC ASSISTED LAPAROSCOPIC VENTRAL HERNIA REPAIR. WHEN THE SCRUB TECH INSERTED THE MESH THROUGH THE PORT, A PIECE OF THE TROCAR BROKE OFF INTO THE PATIENT'S ABDOMEN. THE PIECE WAS REMOVED WITH THE TROCAR. STAFF DID NOT SAVE THE PACKAGING FOR SPECIFIC LOT #, BUT THERE ARE 6 POSSIBLE LOT #S: 1232066, 1259880, 1240711, 1237986, 1225198, 1237515."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    426071 CFS22, 12X100 KII SLEEVE ADVFIX 12/BX GCJ GCJ APPLIED MEDICAL RESOURCES CFS22 UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1