BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MICROLAP CRVD SCISSORS INSERT

    MDR report key: 8934587 · Received August 27, 2019

    Report

    Report Number
    1320894-2019-00291
    Event Type
    Injury
    Date Received
    August 27, 2019
    Date of Event
    August 12, 2019
    Report Date
    August 27, 2019
    Manufacturer
    AB MEDICA SAS
    Product Code
    GCJ
    PMA / PMN Number
    K140101
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION BY THE SERVICE CENTER PER THE INSPECTION PROCEDURE FOUND THAT THE DEVICE PASSED ALL TEST CRITERIA INCLUDING THE INSULATION TEST. A DEVICE HISTORY RECORD REVIEW COULD NOT BE CONDUCTED SINCE THE SERIAL NUMBER OF THE DEVICE WAS NOT AVAILABLE. A SERVICE HISTORY REVIEW COULD NOT BE CONDUCTED SINCE THE SERIAL NUMBER OF THE DEVICE WAS NOT AVAILABLE. PER THE INSTRUCTIONS FOR USE, THE USER IS ADVISED THE FOLLOWING: CAUTIONS: TO AVOID BURNS: ALWAYS KEEP THE WORKING END OF THE PRODUCT IN THE USER'S FIELD OF VISION WHENEVER RF POWER IS ACTIVATED. PRIOR TO EACH USE, VISUALLY INSPECT THE PRODUCT FOR DAMAGE OR SURFACE CHANGES TO THE INSULATION. WHEN USING ACCESSORIES FOR ENDOSCOPY OR LAPAROSCOPY, DEACTIVATE THE AUTOMATIC SWITCH-ON MODE OF THE RF DEVICE. WARNINGS: RISK OF INJURY WHEN USING THE PRODUCT BEYOND THE FIELD OF VIEW. APPLY THE PRODUCT ONLY UNDER VISUAL CONTROL. THIS ISSUE WILL CONTINUE TO BE MONITORED THROUGH THE COMPLAINT SYSTEM TO ASSURE PATIENT SAFETY.

    Description of Event or Problem · 1

    THE SALES REPRESENTATIVE REPORTED ON BEHALF OF THE CUSTOMER THAT THE C-LIL-IP-2SC-31ST DEVICE WAS BEING USED IN A BILATERAL SALPINGECTOMY ON (B)(6) 2019 WHEN A 1ST DEGREE BURN WAS CAUSED TO THE PATIENT' BOWEL WHILE THE DEVICE (SCISSORS) WERE TOUCHING THE DIATHERMY DEVICE. A SECONDARY INCISION WAS REQUIRED FOR THE SURGEON TO BE ABLE TO ENVELOPE/PULL TOGETHER THE BURNED TISSUE FOR SUTURING. THIS CAUSED A 15-MINUTE DELAY IN THE PROCEDURE WHICH WAS THEN COMPLETED SUCCESSFULLY. IT WAS REPORTED THAT THERE WAS NO INJURY TO THE PATIENT. THIS REPORT IS BEING RAISED ON THE BASIS OF INJURY DUE TO SECONDARY INCISION REQUIRED FOR MEDICAL INTERVENTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    731815 MICROLAP CRVD SCISSORS INSERT LAPAROSCOPE, GENERAL & PLASTIC SURGERY GCJ AB MEDICA SAS

    Patients

    Seq Age Sex Outcome Treatment
    1