BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDOPATH ETS FLEX

    MDR report key: 149299 · Received February 12, 1998

    Report

    Report Number
    1527736-1998-00351
    Event Type
    Malfunction
    Date Received
    February 12, 1998
    Report Date
    January 15, 1998
    Manufacturer
    ETHICON ENDO-SURGERY, INC.
    Product Code
    KOG
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    TRACKING #.48882. EES #.980523/C. D5; H2,3,4,6; G4: ADDED ADDITION INFO. D6: CORRECTED FIELD TO READ NA. D6: DEVICE RETURNED WITH NO LOT IDENTIFICATION. D6; DAMAGED REAR CLOSURE CRIMP. ENDOPATH ETS FLEX: BASED ON THE INFO RECEIVED AND THE VISUAL EXAMINATION, IT WAS CONCLUDED THAT THE INSTRUMENT WAS RETURNED WITH THE CLOSURE RING REAR TAB BENT OPEN, WITH A BROKEN RELEASE BUTTON AND WITH SEPARATED HANDLE SHROUDS. NO TESTING COULD BE PERFORMED DUE TO THE CONDITION OF THE RETURNED INSTRUMENT. NO CONCLUSION COULD BE REACHED AS TO HOW THIS DAMAGE OCCURRED. THE RETURNED CARTRIDGE HAD A BENT LOCKOUT TAB ON THE PAN WHICH INDICATES THAT THE INSTRUMENT'S FIRING CYCLE WAS INTERRUPTED, RELEASED, THEN RESTARTED. WHEN THIS OCCURRED, THE LOCKOUT TAB ON THE CARTRIDGE BECAME DAMAGED.

    Description of Event or Problem · 1

    IT WAS REPORTED THE ATB35 WAS USED DURING AN UNKNOWN PROCEDURE. IT WAS REPORTED BY THE AFFILIATE THE STAPLES WOULD NOT DELIVER. THERE WAS NO CONSEQUENCE TO THE PT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ENDOPATH ETS FLEX LINEAR CUTTER KOG ETHICON ENDO-SURGERY, INC. NA NI

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Other