BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

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

    MDR report key: 4963923 · Received July 30, 2015

    Report

    Report Number
    2916714-2015-00649
    Event Type
    Malfunction
    Date Received
    July 30, 2015
    Date of Event
    March 18, 2015
    Report Date
    December 22, 2015
    Manufacturer
    AESCULAP, INC.
    Product Code
    GEI
    PMA / PMN Number
    K110824
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE OTHER CODE FOR 510 (K) IS K130596. U.S. REPORTING AGENT NOTIFIED ON: (B)(4) 2015: MANUFACTURING SITE EVALUATION: ON-GOING.

    Additional Manufacturer Narrative · 1

    (B)(4). MANUFACTURING SITE EVALUATION: THE INSTRUMENT WAS SCRAPPED AT THE HOSPITAL, THEREFOR, AN ANALYSIS OF THE DEVICE WAS NOT POSSIBLE. THE REVIEW OF THE DEVICE QUALITY AND MANUFACTURING HISTORY RECORDS OF BATCH 52053621 WAS COMPLETED. THE QUALITY RECORDS AS WELL AS THE PRODUCTION DOCUMENTS COMPLY WITH SPECIFICATION AND DO NOT PRESENT ANY DISCREPANCIES. BASED ON THE INFORMATION AVAILABLE IT IS NOT POSSIBLE TO DETERMINE A POSSIBLE ROOT CAUSE FOR THE FAILURE, HOWEVER, CORRECTIVE ACTION HAS BEEN INITIATED ON THIS PRODUCT. NO ADDITIONAL ACTION IS NECESSARY AT THIS TIME.

    Description of Event or Problem · 1

    COUNTRY OF COMPLAINT: (B)(6). INSTRUMENT WAS NOT SEALING SUFFICIENTLY. TEMPORARILY UNABLE TO START THE SEALING CYCLE W/THE PUSH BUTTON OF THE INSTRUMENT OR IT WAS NOT POSSIBLE TO STOP W/THE BUTTON. SOMETIMES THE INSTRUMENT STARTED THE CYCLE BY ITSELF, W/OUT PUSHING THE BUTTON. THE MALFUNCTION CAUSED BLEEDING AND IT WAS NECESSARY TO CHANGE THE INSTRUMENT (AN OTHER PL720SU). SURGERY WAS PROLONGED BY APPROXIMATELY 20 MINUTES. DEVICE SCRAPPED AT THE HOSPITAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    495627 CAIMAN DISP. INSTR. NON ARTICUL. D:5/360MM GEI AESCULAP, INC. PL720SU 52053621

    Patients

    Seq Age Sex Outcome Treatment
    1