BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDOPATH ENDOSCOPIC VASCULAR LINEAR CUTTER

    MDR report key: 43062 · Received October 8, 1996

    Report

    Report Number
    1527736-1996-00252
    Event Type
    Malfunction
    Date Received
    October 8, 1996
    Date of Event
    September 9, 1996
    Report Date
    October 8, 1996
    Manufacturer
    ETHICON ENDO-SURGERY, INC.
    Product Code
    GAG
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    9/9/96 1400 ATTEMPTED TO REACH CONTACT PERSON. NO ANSWER. 9/11/95 1055 CONTACTED SOURCE. SHE STATED THERE IS NO OTHER INFO AVAILABLE. A1,2,3,4,B6,7,D10-INFO NOT PROVIDED BY USER FACILITY. H4,D5-INFO NOT AVAILABLE. RESULTS OF EVALUATION: CONCLUSION: BASED UPON THE INQUIRY INFO RECEIVED, THE VISUAL EXAMINATION, AND THE FUNCTIONAL TESTING, NO CONCLUSION COULD BE REACHED AS TO WHY THE INSTRUMENT REPORTEDLY "DID NOT WORK PROPERLY" DURING SURGERY. THE INSTRUMENT WAS RETURNED IN GOOD PHYSICAL CONDITION. THE INSTRUMENT WAS CYCLED, FIRED, CUT, AND FORMED THE STAPLES WITHIN DESIGN SPECIFICATION. THE INSTRUMENT WAS DISASSEMBLED TO EXAMINE THE INTERNAL COMPONENTS AND NO DEFORMATIONS COULD BE ID. IT WAS CONCLUDED THAT THE INSTRUMENT WAS FULLY FUNCTIONAL AND CONFORMING TO DESIGN SPECIFICATIONS. THE EXPERIENCE THE SURGEON REPORTED COULD NOT BE REPEATED. EACH INSTRUMENT IS EVALUATED DURING THE ASSEMBLY PROCESS TO ENSURE IT FUNCTIONS PROPERLY.

    Description of Event or Problem · 1

    THE DEVICE WAS USED DURING AN UNK PROCEDURE. IT WAS REPORTED THAT THE DEVICE WAS RECEIVED BY THE CONTACT PERSON WITH A NOTE STATING THE PRODUCT DID NOT WORK PROPERLY AND THERE WAS NO ADD'L INFO AVAILABLE. THERE WAS NO CONSEQUENCE TO THE PT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ENDOPATH ENDOSCOPIC VASCULAR LINEAR CUTTER ENDOSCOPIC VASCULAR LINEAR CUTTER GAG ETHICON ENDO-SURGERY, INC. NA HG4206

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Required Intervention