BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDOPATH ENDOSCOPIC MULTIFEED STAPLER

    MDR report key: 99719 · Received June 20, 1997

    Report

    Report Number
    1527736-1997-01368
    Event Type
    Malfunction
    Date Received
    June 20, 1997
    Date of Event
    May 21, 1997
    Report Date
    June 19, 1997
    Manufacturer
    ETHICON ENDO-SURGERY, INC.
    Product Code
    GAG
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    FACILITY EXPERIENCED AN EVENT WITH YOUR ENDOPATH ENDOSCOPIC MULTIFEED STAPLER WHILE PERFORMING A UNKNOWN PROCEDURE. THE PRODUCT COMPLAINT ANALYSIS TEAM HAS COMPLETED ITS INVESTIGATION OF THE DEVICE WHICH WAS RETURNED TO CO WITH PRODUCT INQUIRY #973336. THE RESULTS OF THE INVESTIGATION CONDUCTED BY THE APPROPRIATE ENGINEERS AND TECHNICIANS ARE LISTED BELOW. VISUAL INSPECTIONS & RESULTS: NOSE ROTATES A,B)YES, NOSE SHROUD CRACKED/BROKEN A)YES,B)NO, STAPLES IN NOSE A)YES,B)NO, STAPLES IN THE TRACK A,B)YES, TRIGGER ENGAGED WITH PRECOCK A,B)YES. FUNCTIONAL TESTS & RESULTS: CYLCED INSTRUMENT A,B)YES. ANALYSIS CONCLUSION: BASED UPON THE INQUIRY INFO, VISUAL INSPECTION AND FUNCTIONAL TEST PERFORMED, IT WAC CONCLUDED THAT INSTRUMENT (A) MAY HAVE "JAMMED" DURING SURGERY POSSIBLY DUE TO A YIELDED NOSE WELD. NO CONCLUSION COULD BE REACHED AS TO HOW THE NOSE WELD HAD YIELDED. INSTRUMENT (B) WAS CYCLED, FIRED AND FORMED 23 STAPLES WITHOUT INCIDENT. NO CONCLUSION COULD BE REACHED AS TO WHY B REPORTEDLY "JAMMED". IT WAS ORIGINALLY REPORTED THAT ONE INSTRUMENT WAS BEING RETURNED. TWO INSTRUMENTS WERE RECEIVED FOR ANALYSIS. CO REVIEWS EACH INCIDENT AS IT OCCURS IN AN EFFORT TO CONTINUOUSLY IMPROVE THE PRODUCTS AND PROCESS.

    Description of Event or Problem · 1

    IT WAS REPORTED THE DEVICE WAS USED DURING AN UNKNOWN PROCEDURE. IT WAS REPORTED BY THE AFFILIATE THAT THE DEVICE JAMMED AFTER THE SECOND STAPLE. THERE WAS NO PT CONSEQUENCE..

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ENDOPATH ENDOSCOPIC MULTIFEED STAPLER ENDOSCOPIC STAPLER GAG ETHICON ENDO-SURGERY, INC. NA K46659

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Other