BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CAIMAN DISP.INSTR.NON ARTICUL.D:5/360MM

    MDR report key: 5444872 · Received February 18, 2016

    Report

    Report Number
    2916714-2016-00082
    Event Type
    Malfunction
    Date Received
    February 18, 2016
    Date of Event
    December 14, 2015
    Report Date
    May 24, 2016
    Manufacturer
    AESCULAP AG
    Product Code
    GEI
    PMA / PMN Number
    K130596
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS RETURNED IN A CONTAMINATED STATE. THERE IS A CLEAR VISIBLE CHARRING AT THE LEFT SIDE OF THE UPPER JAW. VISIBLE INSPECTION OF THE JAW INDICATED BLOOD SOILING AND CHARRING, HOWEVER, NO OTHER ABNORMALITIES WERE NOTED. MECHANICAL FUNCTION TESTING OF THE RECEIVED DEVICE WAS COMPLETED AND THE CLAMPING AND THE CUTTING FUNCTION WORKED WELL. THE MANUFACTURING DOCUMENTS WERE REVIEWED AND FOUND TO BE ACCORDING TO SPECIFICATION VALID DURING THE TIME OF PRODUCTION. THE MOST PROBABLY ROOT CAUSE IN CASES LIKE THIS IS A IMPROPER CLEANING DURING SURGERY; RESPECTIVELY CLEANING WITH SALINE SOLUTION, SO THAT CARBONIZED RESIDUES OF BLOOD OR TISSUE IN COMMON WITH SALT INITIATE AN ARC. A FURTHER POSSIBLE ROOT CAUSE IS A DAMAGED INSULATION TONGUE (DISSECTION CLIP). THIS DAMAGE IS CREATED BY INCORRECT HANDLING DURING CLEANING THE ELECTRODES. CORRECTIVE / PREVENTIVE ACTION: NOT REQUIRED.

    Additional Manufacturer Narrative · 1

    PRIOR 510(K): K110824.

    Description of Event or Problem · 1

    DURING A TOTAL LAPAROSCOPIC HYSTERECTOMY THE DEVICE SPARKED INSIDE THE PATIENT. DEVICE WAS REMOVED, THERE WAS NO INJURY TO THE PATIENT. SURGICAL DELAY OF APPROXIMATELY 5 MINUTES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    102379 CAIMAN DISP.INSTR.NON ARTICUL.D:5/360MM CUT AND SEAL DEVICE GEI AESCULAP AG PL720SU 52177312

    Patients

    Seq Age Sex Outcome Treatment
    1 Other