BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

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

    MDR report key: 5011606 · Received August 13, 2015

    Report

    Report Number
    2916714-2015-00718
    Event Type
    Malfunction
    Date Received
    August 13, 2015
    Date of Event
    June 26, 2015
    Report Date
    February 25, 2016
    Manufacturer
    AESCULAP AG & CO. KG
    Product Code
    GEI
    PMA / PMN Number
    K110824
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). MANUFACTURING SITE EVALUATION: RECIEVED ONE PL720SU / BATCH NUMBER 52131178 / MANUFACTURE DATE 04/21/2015 FOR EVALUATION. DEVICE DOES NOT DISPLAY ANY OBVIOUS MECHANICAL DAMAGE. RESISTANCE OF THE ACTIVATION BUTTON WAS TESTED. THE RESISTANCE DURING ACTIVATION WAS INDEFINITELY HIGH, EXPECTED RESULTS ARE BETWEEN 0.5 AND 2.5 OHM. ADDITIONAL TESTING OF THIS RESISTANCE WAS COMPLETED USING THE TESTER USED IN PRODUCTION, WHERE THE RESISTANCE MEASURED WAS ACCEPTABLE; FOLLOWED BY MANUAL TESTING WHICH INDICATED THE RESULTS ARE NOT WITHIN THE ACCEPTABLE RANGE. SEVERAL DAYS LATER THE RESISTANCE MEAUSERED WAS AGAIN INDEFINITELY HIGH. THE INCONSISTENT MEASUREMENTS OF THE RESISTANCE OF THE ACTIVIATION BUTTON CAN BE ATTRIBUTED TO RESIDUE ON THE CONTACT SURFACES OF THE SWITCH. MANUFACTURING DOCUMENTS WERE REVIEWED AND FOUND TO BE ACCORDING TO SPECIFICATION VALID DURING THE TIME OF PRODUCTION. THE ROOT CAUSE OF THE DEVICE DEFICIENCY IS A SOILED CONTACT SYSTEM OF THE ACTIVIATION BUTTON. CORRECTIVE ACTION HAS BEEN INITIATED.

    Additional Manufacturer Narrative · 1

    510 (K): K110824 /K130596. US REPORTING AGENT NOTIFIED ON (B)(6) 2015. MANUFACTURING SITE EVALUATION: EVALUATION ON-GOING.

    Description of Event or Problem · 1

    COUNTRY OF COMPLAINT: (B)(6). BUTTON BECAME FIXED WHEN ACTIVATING THE SEALING PROCESS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    533083 CAIMAN DISP. INSTR. NON ARTICUL.D:5 / 360MM CUT AND SEAL DEVICE GEI AESCULAP AG & CO. KG PL720SU 52131178

    Patients

    Seq Age Sex Outcome Treatment
    1 Other