BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

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

    MDR report key: 4954196 · Received July 22, 2015

    Report

    Report Number
    2916714-2015-00616
    Event Type
    Malfunction
    Date Received
    July 22, 2015
    Report Date
    May 20, 2016
    Manufacturer
    AESCULAP AG AND CO. KG
    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

    PMA/510 (K)#: K110824/ K130596. U.S. REPORTING AGENT NOTIFIED ON: 07/13/2015. MFG SITE EVAL: EVAL ON-GOING.

    Additional Manufacturer Narrative · 1

    THE INSTRUMENT ARRIVED IN A CONTAMINATED CONDITION. ACCORDING TO THE AVAILABLE INFORMATION, THERE WERE NO NEGATIVE CONSEQUENCES FOR THE PATIENT. THERE IS A CLEAR VISIBLE CHARRING AT THE RIGHT SIDE OF THE UPPER JAW. TEST APPLIED WAS A DIGITAL-CAMERA. A VISIBLE INSPECTION OF THE JAW. EXCEPT THE BLOOD SOILING AND THE CHARRING FOUND NO FURTHER ABNORMITIES. THE MECHANICAL FUNCTIONS WERE CHECKED. THE CLAMPING AND THE CUTTING FUNCTION WORKED WELL. THE MANUFACTURING DOCUMENTS HAVE BEEN CHECKED AND FOUND TO BE ACCORDING TO SPECIFICATION DURING THE TIME OF PRODUCTION. THE MOST PROBABLY ROOT CAUSE IN CASES LIKE THIS IS A NOT PROPER CLEANING DURING SURGERY, RESPECTIVELY CLEANING WITH SALINE SOLUTION, SO THAT CARBONIZED RESIDUES OF BLOOD OR TISSUE IN COMMON WITH SALT INITIATE ARE ARC. A FURTHER POSSIBLE ROOT CAUSE IS A DAMAGED INSULATION TONGUE (DISSECTION CLIP). THIS DAMAGE CREATED BY WRONG HANDLING DURING CLEANING THE ELECTRODES. ACCORDING TO (B)(4) THE CURRENT FAILURE RATE IS WITHIN THE RISK ANALYSIS AND THEREFORE ACCEPTABLE.

    Description of Event or Problem · 1

    COUNTRY OF COMPLAINT: (B)(6). DEVICE SPARKED DURING USE. GENERATOR DISPLAYED A REGRASP ERROR. ADDITIONAL DEVICE WAS AVAILABLE AND USED TO COMPLETE THE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    476667 CAIMAN DISP. INSTR. NON ARTICUL. D:5/ 360MM CUT AND SEAL DEVICE GEI AESCULAP AG AND CO. KG PL720SU 52108178

    Patients

    Seq Age Sex Outcome Treatment
    1 Other