BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDOPATH THORACIC ENDO LINEAR CUTTER S/SAFTEYLOCK

    MDR report key: 81411 · Received April 2, 1997

    Report

    Report Number
    1527736-1997-00467
    Event Type
    Malfunction
    Date Received
    April 2, 1997
    Date of Event
    March 3, 1997
    Report Date
    April 2, 1997
    Manufacturer
    ETHICON ENDO-SURGERY, INC.
    Product Code
    GAG
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    FACILITY EXPERIENCED AN EVENT WITH THE ENDOPATH THORACIC ENDOSCOPIC LINEAR CUTTER WITH SAFETY LOCK WHILE PERFORMING A THORACOSCOPY. THE PRODUCT COMPLAINT ANALYSIS TEAM HAS COMPLETED ITS INVESTIGATION OF THE DEVICE WHICH WAS RETURNED TO CO WITH PRODUCT INQUIRY #971917. THE RESULTS OF THE INVESTIGATION CONDUCTED BY THE APPROPRIATE ENGINEERS AND TECHNICIANS ARE LISTED BELOW. VISUAL INSPECTIONS & RESULTS: LOCKOUT POSITION, ABC FIRED; CARTRIDGE CONDITION, ABC FULLY FIRED; CARTRIDGE RETURN BATCH NUMBER, A J00G16 B J00E0; AND INSTRUMENT NUMBER, 279. FUNCTIONAL TESTS & RESULTS: CONDITION OF FIRING TRIGGER LOCKOUT, CONDITION OF PINION GEAR, CONDITION OF SHORT RACK, AND CONDITION OF YOKE, GOOD; AND TEST CARTRIDGE BATCH #, J00N7C. ANALYSIS CONCLUSION: BASED UPON THE INQUIRY INFO RECEIVED, THE VISUAL EXAMINATION, AND THE FUNCTIONAL TESTING, NO CONCLUSION COULD BE REAHED AS TO WHY THE INSTRUMENT REPORTEDLY "MISFIRED" DURING SURGERY. THE INSTRUMENT WAS RETURNED IN GOOD PHYSICAL CONDITION. THE INSTRUMENT WAS CYCLED, FIRED, CUT, AND FORMED THE STAPLES WITHIN DESIGN SPECIFICATIONS. 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. EACH INSTRUMENT IS EVALUATED DURING THE ASSMEBLY PROCESS TO ENSURE IT FUNCTIONS PROPERLY. CO STRIVES TO UNDERSTAND EACH INCIDENT AS IT OCCURS IN ORDER TO CONTINUOUSLY IMPROVE THE PRODUCTS.

    Description of Event or Problem · 1

    DURING A THORACOSCOPY, IT WAS REPORTED THE INSTRUMENT WAS FIRED 4 TIMES. ON THE 4TH FIRING, THE STAPLE CARTRIDGE MISFIRED. THERE WAS SOME LEAKAGE WHICH WAS HAND SEWN. REP REPORTS SURGEON FEELS HE DID NOT RECEIVE A CLEAN CUT OR STAPLE LINE. REP RETURNING 3 RELOADS (ZR45B). THERE WAS NO CONSEQUENCE TO THE PT. 3/28/97 REP STATED THE CUSTOMER STATED THE STAPLES DID NOT FORM PROPERLY.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Other