BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OUTER TUBE

    MDR report key: 9865108 · Received March 23, 2020

    Report

    Report Number
    1320894-2020-00138
    Event Type
    Injury
    Date Received
    March 23, 2020
    Date of Event
    March 3, 2020
    Report Date
    May 5, 2020
    Manufacturer
    AB MEDICA SAS
    Product Code
    GCJ
    PMA / PMN Number
    K140101
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    TO DATE, THE REPORTED DEVICE HAS NOT BEEN RETURNED TO CONMED FOR EVALUATION. SHOULD THE DEVICE BE RETURNED AN EVALUATION WILL BE PERFORMED. UPON COMPLETION OF THE COMPLAINT INVESTIGATION A SUPPLEMENTAL AND FINAL REPORT WILL BE FILED. OTHERWISE THIS FILING WILL STAND AS THE FINAL REPORT. THE MANUFACTURING DOCUMENTS FROM THE DEVICE HISTORY RECORD COULD NOT BE REQUESTED DUE TO THE LOT NUMBER OF THE DEVICE BEING UNKNOWN. A DEVICE LOT NUMBER HISTORY COULD NOT BE CONDUCTED DUE TO THE LOT NUMBER OF THE DEVICE BEING UNKNOWN. THIS ISSUE WILL CONTINUE TO BE MONITORED THROUGH THE COMPLAINT SYSTEM TO ASSURE PATIENT SAFETY.

    Additional Manufacturer Narrative · 1

    THE SECOND PRODUCT CODE FOR THIS DEVICE IS GEI. THE REPORTED DEVICE IS BEING RETURNED TO CONMED FOR EVALUATION. A SUPPLEMENTAL AND FINAL REPORT WILL BE FILED FOLLOWING THE COMPLETION OF THE DEVICE EVALUATION AND COMPLAINT INVESTIGATION. THIS ISSUE WILL CONTINUE TO BE MONITORED THROUGH THE COMPLAINT SYSTEM TO ASSURE PATIENT SAFETY.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THE DEVICE, LIL-TU-31, WAS BEING USED DURING AN UNKNOWN TYPE OF PROCEDURE ON (B)(6) 2020 WHEN IT WAS REPORTED THAT ENERGY BREACHED THE SHAFT OF THE INSTRUMENT AND CAUSED A MINOR BURN AT THE PORT SITE OF THE CANNULA. THE PATIENT SUSTAINED AND UNKNOWN DEGREE OF BURN. THE PROCEDURE HAD BEEN COMPLETED SUCCESSFULLY AND THE DOCTOR STATED THAT THE PATIENT WAS "OKAY". FURTHER ASSESSMENT INFORMATION HAS BEEN REQUESTED; HOWEVER, AT THIS TIME THERE HAS BEEN NO FURTHER INFORMATION REPORTED TO THE FACILITY'S SALES REPRESENTATIVE WHO HAS ATTEMPTED TO GAIN THE INFORMATION. THIS REPORT IS BEING RAISED ON THE BASIS OF INJURY DUE TO AN UNKNOWN DEGREE OF BURN TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    332496 OUTER TUBE LAPAROSCOPE, GENERAL & PLASTIC SURGERY GCJ AB MEDICA SAS UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Other