BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDOPATH ENDOSCOPIC ARTICULATING STAPLER

    MDR report key: 82242 · Received January 30, 1997

    Report

    Report Number
    1527736-1997-00057
    Event Type
    Malfunction
    Date Received
    January 30, 1997
    Date of Event
    January 3, 1997
    Report Date
    January 29, 1997
    Manufacturer
    ETHICON ENDO-SURGERY, INC.
    Product Code
    GAG
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    H6; CODE 100: INSTRUMENT RETURNED WITH THE CARTRIDGE BROKEN OFF AND WITH A BROKEN SWIVEL IDLER. BASED UPON THE INQUIRY INFO RECEIVED AND THE VISUAL EXAMINATION, IT WAS CONCLUDED THAT THE REPORTED "LOUD CRACK WAS EXPERIENED" DURING SURGERY WAS THE BREAKAGE OF THE DISTAL SWIVEL IDLER NUB AND THE CARTRIDGE FROM THE INSTRUMENT. THE INSTRUMENT WAS RECEIVED WITH A BROKEN DISTAL IDLER NUB, WHICH WAS NOT RETURNED. THE CARTRIDGE HAD BEEN BROKEN OFF OF THE INSTRUMENT AND IT WAS NOT RETURNED. NO FUNCTIONAL TESTING COULD BE PERFORMED DUE TO BROKEN DISTAL SWIVEL IDLER NUB, WHICH WOULD NOT ALLOW THE RETAINER WASHER TO ROTATE AND ALLOW THE FORMER TO ADVANCE THE STAPLES FROM A TEST CARTRIDGE. NO CONCLUSION COULD BE REACHED AS TO HOW THE DISTAL SWIEL IDLER NUB HAD BECOME BROKEN. EACH INSTRUMENT IS EVALUATED DURING THE ASSEMBLY PROCESS IN ORDER TO ENSURE THAT STAPLES FEED, FIRE AND FORM CORRECTLY. CO STRIVES TO UNDERSTAND EACH INCIDENT AS IT OCCURS IN ORDER TO CONTINUOUSLY IMPROVE THE PRODUCTS.

    Description of Event or Problem · 1

    DURING A LAPAROSCOPIC HERNIA REPAIR, THE SURGEON RELOADED THE OMS AND FIRED SEVERAL TIMES. WITH THE NEXT FIRING, A LOUD CRACK WAS EXPERIENCED. THE OMR AND MOST DISTAL BLACK BAND LABELED WITH THE ORANGE SYMBOL FELL OFF INTO THE ABDOMEN. THE SURGEON CONFIRMED SUCCESSFUL RETRIEVAL OF THE OMR AND BLACK BAND THE OMR20, LOT NUMBER J45MOF, AND BLACK BAND WAS DISCARDED BY THE SRUB NURSE. THERE WAS NO CONSEQUENCE TO THE PT. 1/6/97 THE CASE WAS COMPLETED WITH AN EMS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ENDOPATH ENDOSCOPIC ARTICULATING STAPLER ENDOSCOPIC STAPLERS GAG ETHICON ENDO-SURGERY, INC. NA J45LR

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Other