BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EMS

    MDR report key: 112770 · Received August 12, 1997

    Report

    Report Number
    1527736-1997-01968
    Event Type
    Malfunction
    Date Received
    August 12, 1997
    Date of Event
    July 10, 1997
    Report Date
    July 15, 1997
    Manufacturer
    ETHICON ENDO-SURGERY, INC.
    Product Code
    GAG
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE PRODUCT COMPLAINT ANALYSIS TEAM HAS COMPLETED ITS INVESTIGATION OF THE DEVICE WHICH WAS RETURNED TO CO WITH PRODUCT INQUIRY #974354. THE RESULTS OF THE INVESTIGATION BY THE APPROPRIATE ENGINEERS AND TECHNICIANS ARE LISTED BELOW. VISUAL INSPECTIONS & RESULTS: HEAD ROTATES, YES; NOSE SHROUD CRACKED/BROKEN, YES; STAPLES IN NOSE, YES(6 TWISTED); STAPLES IN THE TRACK YES(13) AND TRIGGER ENGAGED WITH PRECOCK, YES. FUNCTIONAL TESTS & RESULTS: CYCLED INSTRUMENT, NO. ANALYSIS CONCLUSION: BASED UPON THE VISUAL EXAMINATION, INQUIRY INFO AND FUNCTIONAL TEST, IT WAS CONFIRMED THAT THE INSTRUMENT HAD JAMMED. IT IS UNCLEAR AS TO THE EXACT CAUSE OF THE "JAMMING". EXAMINATION REVEALED A CRACKED NOSE NEAR THE WELD SEAM. THIS RESULTED IN THE SEPARATION OF THE NOSE, WHICH DID NOT ALLOW THE DRIVER TO ADVANCE THE FOLLOWING STAPLES. SIX STAPLES WERE FOUND TWISTED IN THE NOSE. NO CONCLUSION COULD BE REACHED WHETHER THE SIX TWISTED STAPLES CAUSED THE NOSE TO CRACK OR IF THE CRACKED NOSE CAUSED THE STAPLES TO BECOME TWISTED. CO REVIEWS EACH INCIDENT AS IT OCCURS IN AN EFFORT TO CONTINUOULSY IMPROVE CO'S PRODUCTS AND PROCESSES.

    Description of Event or Problem · 1

    IT WAS REPORTED DURING A LAPAROSCOPIC HERNIA REPAIR WHEN THE SURGEON ATTEMPTED TO FIRE THE FIRST STAPLE THE INSTRUMENT JAMMED. A NEW EMS WAS PULLED AND USED TO COMPLETE THE CASE. THERE WAS NO CONSEQUENCE TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 EMS ENDOSCOPIC STAPLER GAG ETHICON ENDO-SURGERY, INC. NA K45Z85

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Other