BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDOPATH ELECTROSURGERY PROBE PLUS II

    MDR report key: 155777 · Received March 11, 1998

    Report

    Report Number
    1527736-1998-00695
    Event Type
    Malfunction
    Date Received
    March 11, 1998
    Date of Event
    February 9, 1998
    Report Date
    February 11, 1998
    Manufacturer
    ETHICON ENDO-SURGERY, INC.
    Product Code
    KNS
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    TRACKING #.49538. EES #.981044-2/J. ENDOPATH ELECTROSURGERY PROBE PLUS II: BASED UPON INQUIRY INFO RECEIVED AND VISUAL EXAMINATION NO CONCLUSION COULD BE REACHED AS TO HOW THE REPORTED EVENT OCCURRED. THE SHAFT WAS RECEIVED IN GOOD PHYSICAL CONDITION.

    Description of Event or Problem · 1

    IT WAS REPORTED DURING A LAPAROSCOPIC CHOLECYSTECTOMY THE INSTRUMENT HANDLE AND TIP WERE PUT TOGETHER. THE SCRUB NURSE TESTED THE INSTRUMENT. THE IRRIGATION AND CAUTERY DID NOT WORK. THE DEVICE WAS NOT USED ON A PATIENT. IT WAS REPLACED WITH ANOTHER EPH02 AND EPS02 WHICH FUNCTIONED PROPERLY. THERE WAS NO CONSEQUENCE TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ENDOPATH ELECTROSURGERY PROBE PLUS II ELECTROSURGERY KNS ETHICON ENDO-SURGERY, INC. NA K48A22

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Other