BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HANDLE CEV669B DIA 5MM ANG BIPOLAR

    MDR report key: 3840793 · Received May 30, 2014

    Report

    Report Number
    9680837-2014-00045
    Event Type
    Malfunction
    Date Received
    May 30, 2014
    Report Date
    May 6, 2014
    Manufacturer
    XOMED MICROFRANCE MFG
    Product Code
    GEI
    PMA / PMN Number
    K993655
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS DEVICE IS USED FOR THERAPEUTIC PURPOSES. NOTE: THESE DEVICES WERE RETURNED TOGETHER FROM THE USER FACILITY. BECAUSE THEY ARE DESIGNED TO BE INTERCHANGEABLE, THERE IS NO WAY TO KNOW WHICH DEVICES WERE USED TOGETHER, OR EXACT DATES OF THEIR MALFUNCTION. BECAUSE OF THIS, ALL OF THESE DEVICES ARE BEING REPORTED TOGETHER ON THE SAME REPORT. SUSPECT MEDICAL DEVICE: CEV669B: HANDLE CEV669B DIA 5MM ANG BIPOLAR, LOT 08-06, MANUFACTURED 08 - 2006. CEV669B: HANDLE CEV669B DIA 5MM ANG BIPOLAR, LOT 140103 (X2), MANUFACTURED 01 - 2014. CEV669B: HANDLE CEV669B DIA 5MM ANG BIPOLAR, LOT 120403 (X2), MANUFACTURED 04 - 2012. CEV633-1A: BIPOLAR INSERT CEV633-1A 350MM BOTELLA, LOT 140113, MANUFACTURED 01 - 2014. CEV634-1A: BIPOLAR INSERT CEV634-1A 350MM MOUIEL, LOT 130717, MANUFACTURED 07 - 2013. CONCOMITANT DEVICES: CEV6795B: TUBE CEV6795B DIA 5MM 350MM, LOT 06-05, MANUFACTURED 06 - 2005. CEV6795B: TUBE CEV6795B DIA 5MM 350MM, LOT 09-06, MANUFACTURED 09 - 2005 CEV6795B: TUBE CEV6795B DIA 5MM 350MM, LOT 130901, MANUFACTURED 09 - 2013. CEV6795B: TUBE CEV6795B DIA 5MM 350MM, LOT 131003, MANUFACTURED 10 - 2013. CEV6795B: TUBE CEV6795B DIA 5MM 310MM, LOT UNKNOWN CEV634-1A: BIPOLAR INSERT CEV634-1A 350MM MOUIEL, LOT 130615, MANUFACTURED 06 - 2013. CEV634-1A: BIPOLAR INSERT CEV634-1A 350MM MOUIEL, LOT 200907MF7, MANUFACTURED 7 - 2009. CEV634-1A: BIPOLAR INSERT CEV634-1A 350MM MOUIEL, LOT UNKNOWN. (B)(4). PRODUCT EVALUATION: CEV669B, LOT 02-05 AND LOT 120403 (X2): ANALYSIS FOUND THE BLACK PLASTIC PART OF ALL THE RETURNED HANDLES ARE BURNT AT THE CONNECTION. THE HANDLES ARE IN SHORT CIRCUIT, EXPLAINING THE HEAT DESCRIBED BY THE CLIENT. THE BURN OF THE PLASTIC PART IS THE CONSEQUENCE OF THE FORMATION OF AN ELECTRIC ARC, PROBABLY DUE TO THE PRESENCE OF HUMIDITY IN THE CONNECTION ZONE (CABLE NOT DRIED / BLOOD / TISSUES). THE HANDLES OF THESE TWO LOTS HAVE BEEN REPAIRED BY AN EXTERNAL CONTRACTOR (UNKNOWN ETCHING AND GLUE IN THE SCREWS). CEV669B, LOT 08-06 (X2) AND 140103: ANALYSIS FOUND THE BLACK PLASTIC PART OF ALL THE RETURNED HANDLES ARE BURNT AT THE CONNECTION. THE HANDLES ARE IN SHORT CIRCUIT, EXPLAINING THE HEAT DESCRIBED BY THE CLIENT. THE BURN OF THE PLASTIC PART IS THE CONSEQUENCE OF THE FORMATION OF AN ELECTRIC ARC, PROBABLY DUE TO THE PRESENCE OF HUMIDITY IN THE CONNECTION ZONE (CABLE NOT DRIED / BLOOD / TISSUES). CEV633-1A, LOT 140113: ANALYSIS FOUND THAT THE INSERT IS ON SHORT CIRCUIT. THE ELECTRICAL TESTS FAILED. AFTER DISASSEMBLY, SOME DEFECTS ON THE COATING (INSULATION) APPEARED. THIS PART IS UNDER THE TUBE, WHICH MAKES THE ELECTRICAL RISK FOR THE PATIENT OR THE USER VERY LOW. THE CAUSE OF THIS COATING WEAKNESS IS A DEFECT DURING ITS APPLICATION. CEV634-1A, LOT 130717: ANALYSIS FOUND THAT THIS DEVICE IS ON SHORT AND FAILED THE ELECTRICAL TESTS. AN IMPACT IS OBSERVABLE ON THE COATING (INSULATION) OF THE INSERT WITH THE LOT 130717, EXPLAINING THE SHORT CIRCUIT. THIS IMPACT IS MOST LIKELY TO BE DUE TO A SHOCK WITH ANOTHER INSTRUMENT DURING ITS USE OR ITS REPROCESSING. CEV6795B, LOT 09-06, LOT 131003 AND LOT 130901: ANALYSIS FOUND NO ISSUE HIGHLIGHTED WITH THESE INSTRUMENTS. THESE INSTRUMENTS ARE COMPLIANT WITH MANUFACTURING SPECIFICATIONS. CEV6795B, LOT 06-05 AND LOT UNKNOWN: ANALYSIS FOUND THAT THESE TWO LOTS HAVE BEEN REPAIRED BY AN EXTERNAL CONTRACTOR: UNKNOWN ETCHING AND ERASED MEDTRONIC ETCHING FOR THE UNKNOWN LOT. FOR LOT 06-05, THE BLACK PLASTIC RING AT THE TIP IS MISSING. IT HAS BEEN CONFIRMED BY THE QUALITY ENGINEER THAT THERE IS NO RISK OF DEVICE FRAGMENTS, THE BLACK RING WOULD HAVE BEEN CONTAINED BY THE INSERT. THE BLACK PLASTIC PIECE IS PROBABLY PARTLY DUE TO THE PUNCHING DONE BY THE EXTERNAL SERVICE PROVIDER, WHICH IS MUCH MORE SUPERFICIAL THAN MADE BY MEDTRONIC. CEV634-1A, LOT UNKNOWN: ANALYSIS FOUND THAT THIS INSERT HAS BEEN MODIFIED BY AN EXTERNAL CONTRACTOR. CEV 634-1A, LOT 200907MF7: ANALYSIS FOUND THAT THIS INSERT HAS A DAMAGE COATING (INSULATION) ON ITS DISTAL PART WITHOUT COMPROMISING ITS ELECTRICAL INTEGRITY. THE COATING OF THE INSERT IS PROBABLY DAMAGED BECAUSE OF FRICTION DURING ITS USE. CEV634-1A, LOT 130615: ANALYSIS FOUND NO ISSUE HIGHLIGHTED WITH THIS INSTRUMENT. THIS INSTRUMENT IS COMPLIANT WITH MANUFACTURING SPECIFICATIONS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE DEVICES "DO NOT WORK, THE FORCEPS BURN DURING THEIR USE IN COELIO". IT HAS BEEN CONFIRMED THAT THE DEVICE ITSELF BURNS; THERE HAS BEEN NO PATIENT IMPACT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    318687 HANDLE CEV669B DIA 5MM ANG BIPOLAR ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES GEI XOMED MICROFRANCE MFG CEV669B 02-05

    Patients

    Seq Age Sex Outcome Treatment
    1