BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDOPATH ENDOSCOPIC MULTIFEED STAPLER

    MDR report key: 104689 · Received July 10, 1997

    Report

    Report Number
    1527736-1997-01595
    Event Type
    Malfunction
    Date Received
    July 10, 1997
    Date of Event
    June 11, 1997
    Report Date
    July 9, 1997
    Manufacturer
    ETHICON ENDO-SURGERY, INC.
    Product Code
    GAG
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    FACILITY EXPERIENCED AN EVENT WITH ENDOPATH* ENDOSCOPIC MULTIFEED STAPLER WHILE PERFORMING A COLON RESECTION. THE PRODUCT COMPLAINT ANALYSIS TEAM HAS COMPLETED ITS INVESTIGATION OF THE DEVICE WHICH WAS RETURNED TO CO WITH PRODUCT INQUIRY # 973875. THE RESULTS OF THE INVESTIGATION CONDUCTED BY THE APPROPRIATE ENGINEERS AND TECHNICIANS ARE LISTED BELOW. VISUAL INSPECTIONS & RESULTS: HEAD ROTATES, YES; NOSE SHROUD CRACKED/BROKEN, YES; STAPLES IN NOSE, YES(1); STAPLES IN THE TRACK, YES(12) AND TRIGGER ENGAGED WITH PRECOCK, YES. FUNCTIONAL TESTS & RESULTS: CYLCED INSTRUMENT, YES. ANALYSIS CONCLUSION: BASED UPON THE VISUAL EXAMINATION, INQUIRY INFO AND FUNCTIONAL TEST, IT WAS CONCLUDED THAT THE INSTRUMENT JAMMED DUE TO 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. NO CONCLUSION COULD BE REACHED AS TO HOW THE NOSE HAD BECOME CRACKED. 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 DEVICE WAS USED DURING A LAPAROSCOPIC COLON RESECTION PROCEDURE. IT WAS REPORTED BY THE AFFILIATE THAT THE DEVICE JAMMED. A NEW DEVICE WAS USED TO COMPLETE THE CASE. 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 K4665A

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Other