BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROXIMATE LINEAR CUTTER

    MDR report key: 3963673 · Received July 29, 2014

    Report

    Report Number
    3005075853-2014-05309
    Event Type
    Malfunction
    Date Received
    July 29, 2014
    Date of Event
    July 14, 2014
    Report Date
    July 15, 2014
    Manufacturer
    ETHICON ENDO-SURGERY, LLC.
    Product Code
    GDW
    PMA / PMN Number
    K020779
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION WAS REQUESTED AND THE FOLLOWING WAS OBTAINED: ON WHICH FIRING DID THE EVENT OCCUR (HAD THE DEVICE BEEN USED ON THE PATIENT)? DID THE SURGICAL TECH RECEIVE ANY TYPE OF TREATMENT? IF YES, PLEASE EXPLAIN WHAT TREATMENTS WERE PROVIDED. JUST FOR CLARIFICATION, WAS THE SURGICAL TECH POKED BY A STAPLE(S) OR WERE THE STAPLES DEPLOYED INTO THE TISSUE? IF KNOWN HOW MANY STAPLES WERE DEPLOYED OR HOW MANY POKES WAS THERE? WHEN DID THE EVENT HAPPEN (DURING LOADING THE CARTRIDGE, REMOVING A SPENT CARTRIDGE, ECT)? WHAT TYPE OF PROCEDURE WAS THE DEVICE USED IN? CUSTOMER RESPONSE "WHILE LOADING STAPLE BAR INTO THE DEVICE, DEVICE DEPLOYED WITHOUT PULLING TRIGGER AND STAPLES WENT THROUGH CONTAMINATED GLOVE INTO INDEX FINGER." ON WHICH FIRING DID THE EVENT OCCUR (HAD THE DEVICE BEEN USED ON THE PATIENT)? PRIOR TO THE FIRST FIRING. NO PATIENT INVOLVEMENT. DID THE SURGICAL TECH RECEIVE ANY TYPE OF TREATMENT? THE NURSE IS A TRAVELING NURSE AND BLOOD WAS DRAWN WHICH WAS SET UP BY THE COMPANY THAT SHE WORKS FOR, SEEN BY PRIMARY CARE DOCTOR, TOOK AN ANTIVIRAL FOR A COUPLE OF DAYS AND WAS ALLERGIC SO SHE STOPPED TAKING IT. JUST FOR CLARIFICATION, WAS THE SURGICAL TECH POKED BY A STAPLE(S) OR WERE THE STAPLES DEPLOYED INTO THE TISSUE? THE TIPS OF THE STAPLES STUCK INTO TO SKIN AND SHE PULLED THEM OUT. IF KNOWN HOW MANY STAPLES WERE DEPLOYED OR HOW MANY POKES WAS THERE? UNKNOWN WHEN DID THE EVENT HAPPEN (DURING LOADING THE CARTRIDGE, REMOVING A SPENT CARTRIDGE, ECT)? SHE HANDED THE DEVICE TO THE SURGEON AND THE STAPLE RETAINING CAP WAS OFF. THE SURGEON WAS NOT READY AND HANDED IT BACK TO HER. THE CARTRIDGE WAS HALF WAY OUT AND SHE WAS SNAPPING THE CARTRIDGE BACK INTO PLACE AND THIS IS WHEN IT HAPPENED. WHAT TYPE OF PROCEDURE WAS THE DEVICE USED IN? UNKNOWN.

    Additional Manufacturer Narrative · 1

    (B)(4). ADDITIONAL INFORMATION: THE ANALYSIS RESULTS FOUND THAT THE TCT75 CHANNEL HALF ONLY WAS RECEIVED IN GOOD VISUAL CONDITIONS AND WITH A CARTRIDGE RELOAD PRESENT. THE RELOAD WAS RECEIVED WITH THE 7 MOST PROXIMAL DRIVERS UP AND THE SWING TAB WAS FOUND TO BE IN THE UNLOCKED POSITION. IT SHOULD BE NOTED THAT AFTER THE STAPLE RETAINER HAS BEEN REMOVED, AN INADVERTENT MOVEMENT OF THE FIRING KNOB COULD CAUSE THE WEDGES TO MOVE FORWARD AND THEREFORE CAUSE THE STAPLES TO BECOME DISLODGED. PLEASE REFERENCE THE INSTRUCTION FOR USE FOR MORE INFORMATION. THE DEVICE WAS TESTED FOR FUNCTIONALITY WITH TEST ANVIL HALF AND IT FIRED, CUT AND FORMED ALL THE REMAINING STAPLES AS INTENDED. THE INSTRUMENT FIRED WITHOUT ANY DIFFICULTIES AND THE STAPLES WERE NOTE TO HAVE THE PROPER B-FORMED SHAPE. A BATCH RECORD REVIEW WAS PERFORMED AND THE BATCH HAD NO ANOMALIES NOTED DURING THE MANUFACTURING PROCESS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE, THE DEVICE STAPLED THE SURGICAL TECH. NO FURTHER INFORMATION WAS AVAILABLE. CASE COMPLETED WITH ANOTHER DEVICE OF THE SAME PRODUCT CODE. THERE WERE NO PATIENT CONSEQUENCES REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    442267 PROXIMATE LINEAR CUTTER STAPLE, IMPLANTABLE GDW ETHICON ENDO-SURGERY, LLC. NA L4EC3O

    Patients

    Seq Age Sex Outcome Treatment
    1