BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FORCEPS CEV136 BIPOLAR 350MM GAYET [MXI/XOM]

    MDR report key: 2980120 · Received February 27, 2013

    Report

    Report Number
    9680837-2013-00005
    Event Type
    Injury
    Date Received
    February 27, 2013
    Date of Event
    January 23, 2013
    Report Date
    January 29, 2013
    Manufacturer
    XOMED MICROFRANCE MFG
    Product Code
    GEI
    PMA / PMN Number
    K993655
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THIS DEVICE IS USED FOR THERAPEUTIC PURPOSES. ATTEMPTS TO OBTAIN DETAILED INFORMATION REGARDING PHYSICIAN, PATIENT AND EVENT WERE UNSUCCESSFUL. CEV405, LOT 110102, DATE OF MANUFACTURE 01/2011 (2) CEV405, LOT 110102, DATE OF MANUFACTURE 01/2011 (3) CEV460, LOT 101202, DATE OF MANUFACTURE 12/2010. (B)(4). A TOTAL OF 4 DEVICES WERE RETURNED TO THE MANUFACTURER FOR EVALUATION AND REPAIR. THE INVESTIGATION REPORT FOUND SOME DAMAGE NOTED ON THE SHEATHING OF MONOPOLAR INSTRUMENTS AND THE COATING OF THE BIPOLAR ELECTRODE (DETAILED AS FOLLOWS): CEV136 (QUANTITY 1) - THE ELECTRODE SHORT-CIRCUITED DUE TO IMPROPER MAINTENANCE INDICATED BY PRESENCE OF A SIGNIFICANT AMOUNT OF BIOLOGICAL RESIDUE, AS TO WHERE THE IFU RECOMMENDS USE OF SYSTEMATIC CLEANING. THE ELECTRODE COATING WAS DAMAGED WITH ABRASION TRACES AT THE TIP, PROBABLY FROM REPEATED ABRASION DURING USE OR REPROCESSING. THE BLACK PLASTIC RING WAS ALSO UNSTUCK. CEV405 (QUANTITY 2) - THE INSTRUMENT SHEATHING WAS DAMAGED AND PRESENTED SOME TRACES OF IMPACT FROM SHOCKS OR ABRASION DURING USE OR REPROCESSING. THE JAWS WERE UNSTUCK FROM THE TUBE ON ONE OF THE INSTRUMENTS, ALTHOUGH TURNAROUND WAS POSSIBLE TO REMEDY THE ISSUE. CEV460 (QUANTITY 1) - THE INSTRUMENT SHEATHING WAS DAMAGED AND PRESENTED SOME TRACES OF IMPACT FROM SHOCKS OR ABRASION DURING USE OR REPROCESSING. THE INSTRUMENTS WERE REPAIRED, TESTED TO SPECIFICATIONS AND RETURNED TO THE CUSTOMER. ALTHOUGH THE HIGHLIGHTED DAMAGE COULD NOT BE ESTABLISHED AS THE ORIGIN OF THE REPORTED INCIDENT. BASED ON INVESTIGATION RESULTS AND THE AVAILABLE INFORMATION FROM THE HOSPITAL, WE CAN REASONABLY CONCLUDE THAT THIS EVENT IS NOT IMPUTABLE TO MEDTRONIC.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT 4 LAPAROSCOPIC INSTRUMENTS WERE SENT IN WITH THE REQUEST TO BE INVESTIGATED AND REPAIRED PRIOR TO THE INSTRUMENTS BEING USED AGAIN. IT WAS MENTIONED THAT THE INSTRUMENTS COULD HAVE BEEN INVOLVED IN AN INCIDENT DURING SURGERY, INVOLVING AN INJURY TO THE SMALL INTESTINE. THE HOSPITAL CONFIRMED THE CAUSE OF THE INCIDENT IS "NOT AT FAULT OF ANY MEDICAL DEVICES AND IS VERY LIKELY ASSOCIATED WITH THE SURGICAL ACT."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    84398 FORCEPS CEV136 BIPOLAR 350MM GAYET [MXI/XOM] ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES GEI XOMED MICROFRANCE MFG CEV136 101002

    Patients

    Seq Age Sex Outcome Treatment
    1 Other