BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDOPATH THORACIC ENDO LINEAR CUTTER WITH S/L

    MDR report key: 153493 · Received February 25, 1998

    Report

    Report Number
    1527736-1998-00526
    Event Type
    Malfunction
    Date Received
    February 25, 1998
    Date of Event
    January 28, 1998
    Report Date
    January 28, 1998
    Manufacturer
    ETHICON ENDO-SURGERY, INC.
    Product Code
    GAG
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OK, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    TRACKING #.49149. EES #.980726/C. D5,6; H2,3,4,6; G4: ADDED ADDITION INFO. D6: CORRECTED FIELD TO READ NA. ENDOPATH THORACIC ENDOSCOPIC LINEAR CUTTER WITH SAFETY LOCK: BASED ON THE INQUIRY INFO RECEIVED, THE VISUAL EXAMINATION, AND THE FUNCTIONAL TESTING, NO CONCLUSION COULD BE REACHED AS TO WHY THE INSTRUMENT REPORTEDLY "WOULD NOT OPEN" DURING SURGERY. THE INSTRUMENT WAS RETURNED IN GOOD PHYSICAL CONDITION. THE INSTRUMENT WAS CYCLED, FIRED, CUT, AND FORMED THE STAPLES WITHIN DESIGN SPECIFICATION. THE INSTRUMENT WAS DISASSEMBLED TO EXAMINE THE INTERNAL COMPONENTS AND NO DEFORMATIONS COULD BE IDENTIFIED. IT WAS CONCLUDED THAT THE INSTRUMENT WAS FULLY FUNCTIONAL AND CONFORMING TO DESIGN SPECIFICATIONS. THE EXPERIENCE THE SURGEON REPORTED COULD NOT BE REPEATED.

    Description of Event or Problem · 1

    IT WAS REPORTED THE DEVICE WAS USED DURING A THORACOSCOPY WITH WEDGE RESECTION. IT WAS REPORTED THE SURGEON USED THE EZ45G AND IT CLOSED ON TISSUE ON FIRST FIRING. HE WAS NOT HAPPY WITH POSITIONING, RELEASED INSTRUMENT AND IT WOULD NOT RELEASE. THE BLACK SHEATH WAS COVERING THE JAWS. IT WAS FINALLY OPENED WITH MANIPULATION, THEN THE REAR OF THE CARTRIDGE POPPED UP. THE SURGEON REQUESTED A NEW DEVICE AND ANOTHER WAS OPENED TO COMPLETE THE CASE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ENDOPATH THORACIC ENDO LINEAR CUTTER WITH S/L ENDOSCOPIC LINEAR CUTTER GAG ETHICON ENDO-SURGERY, INC. NA K48U1N

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Other