BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TUBE CEV649-5B DIA 5MM 350MM [MXI/XOM]

    MDR report key: 3022630 · Received March 27, 2013

    Report

    Report Number
    1045254-2013-00303
    Event Type
    Injury
    Date Received
    March 27, 2013
    Date of Event
    February 26, 2013
    Report Date
    March 4, 2013
    Manufacturer
    MEDTRONIC XOMED, INC.
    Product Code
    GEI
    PMA / PMN Number
    K993655
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS DEVICE IS USED FOR THERAPEUTIC PURPOSES. CONCOMITANT DEVICES: PLI 20: CEV10395R, HANDLE CEV10395R DIA 5MM ANG W/O RATCHET, LOT # 08/04, PLI 30: CEV607, SCISSORS INSERT CEV607 6PK DIA 5MM, LOT # UNKNOWN, PLI 40: CEV607-1, INSERT CEV607-1 FOR SCISSORS JAWS, LOT # 09/04. (B)(4). EVALUATION SUMMARY: THE DEVICES WERE RETURNED FOR ANALYSIS. ANALYSIS OF CEV649-5B (PLI 10) FOUND THE TUBE SHEATHING WAS DAMAGED WITH TRACES OF IMPACT. ELECTRICAL TESTS CONFIRMED THE TUBE TO BE WITHIN SPECIFICATIONS. ANALYSIS OF CEV10395R (PLI 20) FOUND NO ISSUES WITH THE DEVICE. THE INSTRUMENT WAS WITHIN SPECIFICATIONS. ANALYSIS OF CEV607 (PLI 30) FOUND THE BLACK PLASTIC PIECE TO BE SLIGHTLY DAMAGED; MOST LIKELY EXPERIENCED DURING USE OR REPROCESSING. THE SCISSORS' BLADES WERE ALSO BLUNT AND IN NEED OF SHARPENING. ANALYSIS OF CEV607-1 (PLI 40) FOUND NO ISSUE WITH THE DEVICE. THE INSTRUMENT WAS WITHIN SPECIFICATIONS. NO MALFUNCTIONS THAT COULD EXPLAIN THE REPORTED EVENT HAVE BEEN DETECTED ON THE INSTRUMENTS RETURNED. IT IS VERY LIKELY THAT THE ELECTRICAL SHOCK FELT BY THE SURGEON IS THE CONSEQUENCE OF THE FORMATION OF AN ELECTRICAL ARC DUE TO THE NON-VOLUNTARY CONTACT WITH THE PATIENT BODY DURING COAGULATION OR THE WEARING OF GLOVES WHICH WERE DAMAGED OR WITH DEGRADED ISOLATING PROPERTIES (PERSPIRATION / RESIDUES / BLOOD).

    Additional Manufacturer Narrative · 1

    (B)(4)

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE SURGEON FELT AN ELECTRICAL SHOCK DURING THE PROCEDURE. THEY STATED THAT THERE WAS NO USER/PATIENT IMPACT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    125059 TUBE CEV649-5B DIA 5MM 350MM [MXI/XOM] ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES GEI MEDTRONIC XOMED, INC. CEV649-5B 101007

    Patients

    Seq Age Sex Outcome Treatment
    1 (B)(4)