BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDOPATH ENDOSCOPIC MULTIFEED STAPLER

    MDR report key: 109563 · Received July 29, 1997

    Report

    Report Number
    1527736-1997-01833
    Event Type
    Malfunction
    Date Received
    July 29, 1997
    Report Date
    July 1, 1997
    Manufacturer
    ETHICON ENDO-SURGERY, INC.
    Product Code
    GAG
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    FACILITY EXPERIENCED AN EVENT WITH ENDOPATH* ENDOSCOPIC MULTIFEED STAPLER WHILE PERFORMING A LAP BURCH/USI. THE PRODUCT COMPLAINT ANALYSIS TEAM HAS COMPLETED ITS INVESTIGATION OF THE DEVICE WHICH WAS RETURNED TO CO WITH PRODUCT INQUIRY # 974095. 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(3 TWISTED); STAPLES IN THE TRACK, YES(8) AND TRIGGER ENGAGED WITH PRECOCK, YES. FUNCTIONAL TESTS & RESULTS: CYCLED INSTRUMENT, YES. ANALYSIS CONCLUSION: BASED UPON THE VISUAL EXAMINATION, INQUIRY INFO AND FUNCTIONAL TEST, IT WAS CONCLUDED THAT THE INSTRUMENT JAMMED DUE TO THREE TWISTED STAPLES JAMMED IN THE CARTRIDGE NOSE OR DUE TO THE 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 WHETHER THE TWISTED STAPLES IN THE NOSE CAUSED THE NOSE TO CRACK OR IF THE CRACKED OSE CAUSED THE STAPLES TO BECOME TWISTED. CO REVIEWS EACH INCIDENT AS IT OCCURS IN AN EFFORT TO CONTINUOUSLY IMPROVE CO'S PRODUCTS.

    Description of Event or Problem · 1

    IT WAS REPORTED DURING THE LAPAROSCOPIC BURCH PROCEDURE, THE REP STATED THE STAPLES SEEMED TO BE MISFORMING INTO THE COOPER LIGAMENT. ANOTHER EMS WAS OPENED TO COMPLETE THE CASE. THERE WAS NO CONSEQUENCE TO THE PT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ENDOPATH ENDOSCOPIC MULTIFEED STAPLER ENDOSCOPIC STAPLER GAG ETHICON ENDO-SURGERY, INC. NA K4653

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Other