BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MICROLAP INSULTATED OUTER TUBE

    MDR report key: 8134252 · Received December 5, 2018

    Report

    Report Number
    1320894-2018-00260
    Event Type
    Malfunction
    Date Received
    December 5, 2018
    Date of Event
    November 8, 2018
    Report Date
    January 8, 2019
    Manufacturer
    AB MEDICA SAS
    Product Code
    GCJ
    PMA / PMN Number
    K140101
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE REPORTED DEVICE IS BEING RETURNED TO THE PRIVATE LABEL MANUFACTURER FOR EVALUATION. A SUPPLEMENTAL AND FINAL REPORT WILL BE FILED FOLLOWING THE COMPLETION OF THE DEVICE EVALUATION AND COMPLAINT INVESTIGATION.

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS VISUALLY INSPECTED BY A CONMED LAB TECHNICIAN. ONE C-LIL-TU-31 WAS RECEIVED IN OPENED UNORIGINAL PACKAGING. THE REPORTED CATALOG AND LOT NUMBERS WERE VERIFIED. VISUAL INSPECTION OF THE DEVICE FOUND THAT THE INSULATION ON THE SHAFT WAS DAMAGED APPROXIMATELY 5.5 INCHES FROM THE DISTAL END. THE PECULIAR LIGHT REFERENCED IN THE COMPLAINT IS LIKELY ARCING "FORM" THE EXPOSED AREA OF THE SHAFT WHERE THE INSULATION HAS BEEN COMPROMISED. REQUEST FOR THE EVALUATION HAVE BEEN SENT TO THE MANUFACTURER. SHOULD THE EVALUATION BE RECEIVED A FOLLOW UP REPORT WILL BE FILED. OTHERWISE THIS FILING WILL STAND AS THE FINAL REPORT. A TWO-YEAR REVIEW OF COMPLAINT HISTORY REVEALED THERE HAS BEEN A TOTAL OF ONE (1) COMPLAINT, REGARDING ONE (1) DEVICE, FOR THIS DEVICE FAMILY AND FAILURE MODE. DURING THE SAME TIME FRAME (B)(4) DEVICES HAVE BEEN MANUFACTURED AND SHIPPED WORLDWIDE. THE REPORTED RATE OF FAILURE FOR THIS DEVICE AND FAILURE MODE: (B)(4). PER THE INSTRUCTIONS FOR USE, THE USER IS ADVISED THE FOLLOWING: INSPECT THE PRODUCT FOR LOOSE, BENT, BROKEN, CRACKED, WORN OR FRACTURED COMPONENTS PRIOR TO EACH USE. THIS ISSUE WILL CONTINUE TO BE MONITORED THROUGH THE COMPLAINT SYSTEM TO ASSURE PATIENT SAFETY.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THE SURGEON NOTICED A PECULIAR LIGHT FROM WITHIN THE ABDOMEN OF THE PATIENT AND ASKED THE ASSISTANT TO WATCH THE PATIENT'S BELLY WHILST SHE USED THEC-LIL-TU-31, MICRO LAP BENT SCISSOR, WITH THE MONOPOLAR DIATHERMY ATTACHED. SHE NOTICED NO STRANGE LIGHT AS THE DEVICE WAS BEING USED FOR THE FIRST 5 OR 6 ELECTROSURGICAL USES. AFTER SOME USE SHE SAW A BLUE LIGHT FROM WITHIN THE PERITONEAL CAVITY. THE ASSISTANT ADVISED THE SURGEON TO STOP USING THE INSTRUMENT AND REMOVE IT FOR INSPECTION. UPON INSPECTION THE INSULATION OF THE MICRO LAP SCISSORS WAS DAMAGED, AND METAL COULD BE SEEN. IT APPEARS THE DAMAGED INSULATION CAUSED A MINOR BURN TO THE PATIENT'S FALLOPIAN TUBE. THE INSULATING TUBING WAS CHANGED, AND THE PROCEDURE CONTINUED AS PLANNED. THE SURGEON CONCLUDED IT WAS A MINOR BURN AND NO MAJOR DAMAGE WAS DONE, NOR WOULD IT REQUIRE ANY ADDITIONAL TREATMENT. THERE WAS A REPORTED 2-MINUTE DELAY IN SURGERY. THIS REPORT IS BEING RAISED BASED ON DEVICE MALFUNCTION WITH POTENTIAL FOR INJURY UPON REOCCURRENCE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    975550 MICROLAP INSULTATED OUTER TUBE LAPAROSCOPIC ELECTRODE GCJ AB MEDICA SAS

    Patients

    Seq Age Sex Outcome Treatment
    1 16 YR