BEUDAMED
    FDA Adverse Event Summary report: N

    ENDOPATH*5MM CURVED SCISSORS

    MDR report key: 1915230 · Received December 6, 2010

    Report

    Report Number
    3005075853-2010-06888
    Date Received
    December 6, 2010
    Date of Event
    November 2, 2010
    Report Date
    November 24, 2010
    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
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). INFORMATION ANTICIPATED, BUT UNAVAILABLE AT THIS TIME.

    Additional Manufacturer Narrative · 1

    (B)(4). ADDITIONAL INFORMATION: UPON REVIEW OF THE INFORMATION PROVIDED, IT WAS CONCLUDED THAT THIS EVENT DOES NOT MEET THE FDA DEFINED CRITERIA FOR A REPORTABLE EVENT, AND IS BEING CONSIDERED NOT REPORTABLE. THE ANALYSIS RESULTS CONFIRMED THAT ONE INSTRUMENT WAS RECEIVED IN GOOD VISUAL CONDITION. IN AN ATTEMPT TO REPLICATE THE REPORTED INCIDENT, THE DEVICE WAS TESTED FOR FUNCTIONALITY. UPON TESTING OF THE DEVICE, THE ROTATION FEATURE PERFORMED AS INTENDED AND THE TRIGGER CLOSED AND OPENED AS INTENDED; NO ANOMALIES WERE NOTED. NO CONCLUSION COULD BE REACHED AS TO WHAT MAY HAVE CAUSED THE REPORTED INCIDENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A LAPAROSCOPIC UROLOGICAL PROCEDURE, IT HAD A DIFFICULTY IN ROTATING THE ROTATE KNOB. BESIDES, IT WAS HARD TO GRASP THE HANDLE. ANOTHER DEVICE WAS USED TO COMPLETE THE CASE. THERE WERE NO ADVERSE CONSEQUENCES FOR THE PATIENT.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1