BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

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

    MDR report key: 3786512 · Received March 21, 2014

    Report

    Report Number
    2916714-2014-00204
    Event Type
    Malfunction
    Date Received
    March 21, 2014
    Date of Event
    December 10, 2013
    Report Date
    March 21, 2014
    Manufacturer
    B. BRAUN SURGICAL S.A.
    Product Code
    GEI
    PMA / PMN Number
    K1110824
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL PMA/510 (K): K130596. MFG SITE EVALUATION: EVALUATION ON-GOING.

    Description of Event or Problem · 1

    DURING A LAPAROSCOPIC HYSTERECTOMY WHILE SEALING TISSUE, SPARKING WAS OBSERVED. NO IMPACT TO PT TISSUE. PT WAS NOT INJURED. SURGERY DELAYED MOMENTARILY, LESS THAN FIVE MINUTES TO RETRIEVE ANOTHER DEVICE. NO ADDITIONAL INTERVENTION REQUIRED. SURGERY WAS COMPLETED AS EXPECTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    168849 CAIMAN DISP. INSTR. NON ARTICUL. D:5/360MM VESSEL SEALING INSTRUMENT GEI B. BRAUN SURGICAL S.A. PL720SU 24650061

    Patients

    Seq Age Sex Outcome Treatment
    1 Other