BEUDAMED
    FDA Adverse Event Summary report: N

    ENDOPATH ENDOSCOPIC MULTIPLE CLIP APPLIER

    MDR report key: 57984 · Received October 4, 1996

    Report

    Report Number
    1628808-1996-00061
    Date Received
    October 4, 1996
    Date of Event
    September 3, 1996
    Report Date
    October 4, 1996
    Manufacturer
    ETHICON ENDO-SURGERY, INC.
    Product Code
    GDO
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    9/11/96 1625 ATTEMPTED CONTACT WITH THE REPROTED CONTACT PERSON, BUT WAS TOLD THERE IS NO ONE THERE BY THAT NAME IN THE OPERATING ROOM. CONFIRMED WITH WRITTEN CHECKLIST, WILL TRY AGAIN. 9/12/96 1035 LEFT PHONEMAIL MESSAGE AND 800# FOR CONTACT PERSON TO CALL BACK. 9/13/96 NNCI SENT. A1,2,3,4,B6,7,D10-INFORMATION NOT PROVIDED BY USER FACILITY. H4,8,D5-INFORMATION NOT AVAILABLE. CONCLUSION: BASED UPON THE INQUIRY INFOMRATION RECEIVED, THE VISUAL EXAMINATION, AND THE FUNCTIONAL TESTING, NO CONCLUSION COULD BE REACHED AS TO WHAT MAY HAVE CAUSED THE REPORTED INCIDENT. THE INSTRUMENT WAS RETURNED IN GOOD PHYSICIAL CONDITION. THE INSTRUMENT WAS CYCLED, FED, AND FORMED THE CLIPS WITHIN DESIGN SPECIFICATION WHEN TESTED. IT WAS CONCLUDED THAT THE INSTRUMENT WAS CONFORMING TO DESIGN SPECIFICATIONS. THE EXPERIENCE THE SURGEON REPORTED COULD NOT BE REPEATED. EACH INSTRUMENT IS EVALUATED DURING THE ASSEMBLY PROCESS TO ENSURE THE CLIPS FEED AND FORM PROPERLY.

    Description of Event or Problem · 1

    THE APPLIER WAS USED DURING AN UNKNOWN PROCEDURE. THE CLIPS WERE MISALIGNED AND FELL-OFF.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ENDOPATH ENDOSCOPIC MULTIPLE CLIP APPLIER ENDOSCOPIC MULTIPLE CLIP APPLIER GDO ETHICON ENDO-SURGERY, INC. NA J43VB7

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Other