BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

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

    MDR report key: 4658429 · Received March 27, 2015

    Report

    Report Number
    2916714-2015-00251
    Event Type
    Malfunction
    Date Received
    March 27, 2015
    Date of Event
    February 20, 2015
    Report Date
    December 22, 2015
    Manufacturer
    AESCULAP AP & CO. KG
    Product Code
    GEI
    PMA / PMN Number
    NARRATIVE
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    510K/PMA: K093075 / K130596. EVALUATION ON-GOING.

    Additional Manufacturer Narrative · 1

    MANUFACTURING SITE EVALUATION: REVIEW OF COMPLAINT PRODUCT NOT POSSIBLE, AS DEVICE WAS NOT RECEIVED. REVIEW OF DATABASE INDICATES NO OTHER COMPLAINTS FOR THE REPORTED LOT NUMBER.

    Description of Event or Problem · 1

    LAPAROSCOPIC HYSTERECTOMY; SEALING OF VESSEL + TISSUE; TISSUE TYPE: MESENTERY. THE DEVICE WAS NEVER USED ON THE PT. THE FIRE STARTED WHEN IT WAS PLUGGED IN BEFORE IT WAS PUT INTO THE PT. DR. WAS USING THE DEVICE WHEN THEY PLUGGED IT INTO THE GENERATOR IT SPARKED AND CREATED A BALL OF FIRE ON THE TIP OF THE CAIMAN. THEY PUT THE FIRE OUT, OPENED UP ANOTHER DEVICE AND PLUGGED IT INTO THE SAME GENERATOR. THEY DID NOT RECORD WHICH GENERATOR WAS BEING USED. NO PT INJURY, SURGICAL DELAY OF 15 MIN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    205181 CAIMAN DISP. INSTR. NON ARTICUL. D:5/360MM CUTTING AND SEALING DEVICE GEI AESCULAP AP & CO. KG PL720SU 52102065

    Patients

    Seq Age Sex Outcome Treatment
    1 Other