BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIGACLIP ENDOSCOPIC MULTIPLE CLIP APPLIER

    MDR report key: 56025 · Received December 12, 1996

    Report

    Report Number
    1527736-1996-00645
    Event Type
    Malfunction
    Date Received
    December 12, 1996
    Date of Event
    November 12, 1996
    Report Date
    December 10, 1996
    Manufacturer
    ETHICON ENDO-SURGERY, INC.
    Product Code
    GDO
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    DURING A LAPAROSCOPIC CHOLECYSTOMY THE SURGEON FIRED THE ER42 ACROSSED THE CYSTIC DUCT AND THE CLIP SCISSORED. THIS HAPPENED WITH REPEATED FIRINGS OF THE DEVICE. A SECOND DEVICE WAS OPENED AND THE CLIPS ALSO SCISSORED. AN ER320 WAS OPENED TO COMPLETE THE PROCEDURE. A CLIP IS BEING RETURNED WITH THE DEVICE. THERE WAS NO CONSEQUENCE TO THE PT. 11/20/96 1430 SURGEON CALLED BACK AND CONFIRMED THE INFO AS REPORTED BY THE REP. HE STATED THE FIRST FIRING OF THE FIRST INSTRUMENT FIRED WITHOUT DIFFICULTY AND THE CLIP WAS CORRECTLY FORMED. THE NEXT FIRINGS FIRED SCISSORED CLIPS. ANOTHER INSTRUMENT WAS ALSO USED AND IT FIRED ALL SCISSORED CLIPS. HE DID NOT NOTICE ANY UNUSUAL TACTILE OR AUDIBLE FEEDBACK. THE SCISSSORING WAS NOT NOTICED UNTIL THE SURGEON WENT TO PLACE AN ENDO-LOOP ON THE CYSTIC DUCT BECAUSE IT WAS INFLAMMED. WHEN PLACING THE ENDO-LOOP, THE CLIPS WERE BEING REMOVED AND NOTED TO BE SCISSORED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LIGACLIP ENDOSCOPIC MULTIPLE CLIP APPLIER ENDOSCOPIC CLIP APPLIER GDO ETHICON ENDO-SURGERY, INC. NA J4400T

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Other