BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDOPATH ENDOSCOPIC MULTIFEED STAPLER

    MDR report key: 112243 · Received August 7, 1997

    Report

    Report Number
    1527736-1997-01920
    Event Type
    Malfunction
    Date Received
    August 7, 1997
    Report Date
    July 11, 1997
    Manufacturer
    ETHICON ENDO-SURGERY, INC.
    Product Code
    GAG
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    THE PRODUCT COMPLAINT ANALYSIS TEAM HAS COMPLETED ITS INVESTIGATION. THE RESULTS OF THE INVESTIGATION CONDUCTED BY THE APPROPRIATE ENGINEERS AND TECHNICIANS ARE LISTED BELOW. VISUAL INSPECTIONS & RESULTS: HEAD ROTATES, ABC)YES; NOSE SHROUD CRACKED/BROKEN AC)NO,B)YES; STAPLES IN NOSE, AC)NO,B)YES(5); STAPLES IN THE TRACK, AC(0),B(11) AND TRIGGER ENGAGED WITH PRECOCK, ABC)YES. FUNCTIONAL TESTS & RESULTS: CYCLED INSTRUMENT, AC)NO,B)YES. ANALYSIS CONCLUSION: BASED UPON THE INQUIRY INFO RECEIVED, VISUAL EXAMINATION AND FUNCTIONAL TEST, IT WAS CONCLUDED THAT THE REPORTED "DEVICES JAMMED" DURING SURGERY OCCURRED POSSIBLY DUE TO FIVE STAPLES JAMMED IN THE NOSE AND A YIELDED CARTRIDGE NOSE WELD FORM INSTRUMENT (B). THE DEVICE FIRED TWO STAPLES WELL FORMED FOLLOWED BY FIVE MALFORMED STAPLES DUE TO THE YIELDED NOSE WELD. NO CONCLUSION COULD BE REACHED WHETHER THE FIVE STAPLES JAMMED IN THE NOSE CAUSED THE NOSE WELD TO YIELD, OR IF THE YIELDED NOSE WELD CAUSED THE FIVE STAPLES TO BECOME JAMMED IN THE NOSE. INSTRUMENTS (A) AND (C) WERE RECEIVED EMPTY IN GOOD PHYSICAL CONDITION. CO REVIEWS EACH INCIDENT AS IT OCCURS IN AN EFFORT TO CONTINUOUSLY IMPROVE CO'S PRODUCTS AND PROCESSES.

    Description of Event or Problem · 1

    IT WAS REPORTED THE DEVICES WERE USED DURING AN UNK PROCEDURE. IT WAS REPORTED BY THE AFFILIATE THAT THE DEVICES JAMMED. IT WAS NOT REPORTED IF THERE WERE ANY PT CONSEQUENCES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ENDOPATH ENDOSCOPIC MULTIFEED STAPLER ENDOSCOPIC STAPLER GAG ETHICON ENDO-SURGERY, INC. NA J43K72

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Other