BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDOPATH 5MM CURVED SCISSORS

    MDR report key: 3872145 · Received June 13, 2014

    Report

    Report Number
    3005075853-2014-03979
    Event Type
    Malfunction
    Date Received
    June 13, 2014
    Date of Event
    May 15, 2014
    Report Date
    May 20, 2014
    Manufacturer
    ETHICON ENDO-SURGERY, LLC.
    Product Code
    GEI
    PMA / PMN Number
    K984240
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). ADDITIONAL INFORMATION WAS REQUESTED AND THE FOLLOWING WAS OBTAINED: DID ANY PART OF BLACK COVERING ON SHAFT OF DEVICE FALL OFF INTO PATIENT? NOT TO MY KNOWLEDGE. IF SO, WAS BLACK COVERING RETRIEVED FROM PATIENT? WAS BLACK COVERING CUT BY ANOTHER DEVICE? NO HOW WAS CASE COMPLETED? ANOTHER DEVICE WAS PULLED.

    Additional Manufacturer Narrative · 1

    (B)(4). ADDITIONAL INFORMATION: DAMAGED SHRINK TUBE. THE 5DCS INSTRUMENT WAS RETURNED WITH THE SHRINK TUBE DAMAGED. THE DAMAGE FOUND WAS NOTED THROUGHOUT THE LINKS AREA. A POTENTIAL CAUSE OF THIS DAMAGE IS THE CONTACT OF THE SHRINK TUBE WITH A SHARP OR AN ENERGIZED DEVICE. PLEASE NOTE THAT AS PART OF OUR QUALITY PROCESS, EACH DEVICE IS VISUALLY INSPECTED AND FUNCTIONALLY TESTED DURING MANUFACTURING TO ENSURE THAT THE DEVICE MEETS THE REQUIRED SPECIFICATIONS PRIOR TO SHIPMENT. THE BATCH RECORD WAS REVIEWED AND NO ANOMALIES WERE NOTED DURING THE MANUFACTURING PROCESS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE, THE TECH STATED THAT "THE BLACK COVERING ON THE SCISSORS, SPLIT OFF THE TOP". THERE WERE NO PATIENT CONSEQUENCES. UNKNOWN HOW CASE WAS COMPLETED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    349863 ENDOPATH 5MM CURVED SCISSORS ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES GEI ETHICON ENDO-SURGERY, LLC. NA L4EE6L

    Patients

    Seq Age Sex Outcome Treatment
    1