BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDOPATH ENDOSCOPIC MULTIFEED STAPLER

    MDR report key: 108136 · Received July 24, 1997

    Report

    Report Number
    1527736-1997-01788
    Event Type
    Malfunction
    Date Received
    July 24, 1997
    Date of Event
    June 26, 1997
    Report Date
    June 26, 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 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 #974190. 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 INVERTED); STAPLES IN TRACK, YES(10) AND TRIGGER ENGAGED WITH PRECOCK, YES. FUNCTIONAL TESTS & RESULTS: CYLCED INSTRUMENT, NO. ANALYSIS CONCLUSION: BASED UPON THE INQUIRY INFO RECEIVED AND THE VISUAL EXAMINATION, IT WAS CONCLUDED THAT THE REPORTED INSTRUMENT "STAPLES WOULD NOT ADVANCE" DURING SURGERY MAY HAVE BEEN DUE TO AN INVERTED STAPLE IN THE CARTRIDGE NOSE AND A YIELDED CARTRIDGE NOSE WELD, WHICH CAUSED THE INSTRUMENT TO JAM. NO CONCLUSION COULD BE REACHED WHETHER THE YIELDED CARTRIDGE NOSE WELD HAD CAUSED THE STAPLE TO INVERT OF THE INVERTED STAPLE HAD CAUSED THE CARTRIDGE NOSE WELD TO YIELD. CO REVIEWS EACH INCIDENT AS IT OCCURS IN AN EFFORT TO CONTINUOUSLY IMPROVE THE PRODUCTS AND PROCESSES.

    Description of Event or Problem · 1

    THE DEVICE WAS USED DURING AN UNKNOWN PROCEDURE. IT WAS REPORTED BY THE AFFILIATE THAT THE STAPLES WOULD NOT ADVANCE. THERE WAS NO PATIENT 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 K46C07

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Other