BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SCISSORS INSERT CEV605G 3PK 350MM

    MDR report key: 3338522 · Received August 29, 2013

    Report

    Report Number
    9680837-2013-00396
    Event Type
    Malfunction
    Date Received
    August 29, 2013
    Date of Event
    March 6, 2013
    Report Date
    March 8, 2013
    Manufacturer
    MEDTRONIC XOMED INSTRUMENTATION S.A.S.
    Product Code
    GEI
    PMA / PMN Number
    K993655
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    ADD'L DEVICES: CEV605G (LOT #120202) - MFG DATE: FEBRUARY 2012 - QTY4; CEV605G (LOT #UNK) - MFG DATE: UNK - QTY 1; CEV605G (LOT #120201) - MFG DATE: FEBRUARY 2012 - QTY4. SAMPLES FROM LOT #120202, WERE EVALUATED AND INDICATED ALL SHOWED DAMAGE TO THE BLACK PLASTIC SKIRTS TO A GREATER OR LESSER EXTENT. THE BLADES WERE ALSO BLUNT AND NEED TO BE SHARPENED. TWO OF THE SAMPLES PRESENT OXIDIZED PINS WITH TRACES OF CORROSION. FINALLY, ONE OF THE SAMPLES HAS ONE OF THE MOBILE BLADES BROKEN. THE DAMAGE OBSERVED WITH THE PLASTIC SKIRTING WAS VERY LIKELY THE CONSEQUENCE OF ABNORMAL USE WITH SHOCK OR EXCESSIVE FORCE FROM THE SCISSORS EXITING THE TROCAR. LOT #UNK WAS EVALUATED AND INDICATED THAT THE BLADES WERE BLUNT AND NEED TO BE SHARPENED. THE RETURNED SAMPLE PRESENTS A BROKEN BLADE. NO MATERIAL AND MFG DEFECT WAS DETECTED. SAMPLES FROM LOT #120201 WERE EVALUATED AND INDICATED THAT ALL SHOWED DAMAGE TO THE BLACK PLASTIC SKIRTS TO A GREATER OR LESSER EXTENT. THE BLADES WERE ALSO BLUNT AND NEED TO BE SHARPENED. ONE OF THE RETURNED SAMPLES SHOWED BROKEN THREADING. THE DAMAGE OBSERVED WITH THE PLASTIC SKIRTING WAS VERY LIKELY THE CONSEQUENCE OF ABNORMAL USE WITH SHOCK OR EXCESSIVE FORCE FROM THE SCISSORS EXITING THE TROCAR. THE BLADES WERE BLUNT AND NEED TO BE SHARPENED. THE SAMPLE WITH THE BROKEN THREADING WAS VERY LIKELY SUBJECTED TO EXCESSIVE FORCE LEADING TO THE BREAK. (ATTEMPT TO DISASSEMBLE THE SKIRTING WITH FORCEPS). NOTE: THIS MDR IS BEING FILED AS A RESULT OF AN INTERNAL REVIEW OF COMPLAINTS FROM MEDTRONIC'S (B)(6). THIS REVIEW WAS CONDUCTED TO RESOLVE SEVERAL ISSUES DISCOVERED IN THE MXI COMPLAINT HANDLING PROCESS. ISSUES RESOLVED INCLUDE THE MISCLASSIFICATION OF DEVICES RETURNED FOR REPAIR, AS WELL AS GAPS IN REPORTING. MXI CAPA (B)(4) WAS OPENED TO ADDRESS THESE ISSUES. COMPLAINANT/FACILITY: (B)(6).

    Description of Event or Problem · 1

    TEN DEVICES (PART# CEV605G) WERE RETURNED TO MXI SERVICE AND REPAIR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    424975 SCISSORS INSERT CEV605G 3PK 350MM GEI MEDTRONIC XOMED INSTRUMENTATION S.A.S. CEV605G 120202

    Patients

    Seq Age Sex Outcome Treatment
    1