BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROXIMATE** RELOADABLE LINEAR STAPLER

    MDR report key: 3030590 · Received April 2, 2013

    Report

    Report Number
    3005075853-2013-01546
    Event Type
    Malfunction
    Date Received
    April 2, 2013
    Date of Event
    October 2, 2012
    Report Date
    October 16, 2012
    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
    GR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). DAMAGED ADJUSTING KNOB AND LOCKOUT SLIDE TIP DAMAGED. DEVICE B: BATCH# J5HH6Y, EXPIRATION DATE: 08/01/2012, MANUFACTURING DATE: 07/01/2007. ON WHAT TISSUE TYPE WAS THE DEVICE USED? LUNG PARENCHYMA. ON WHICH FIRING(S) DID THIS EVENT OCCUR (1ST, 2ND, 3RD., ETC)? FIRST. WHERE IN THE GREEN ZONE WAS THE DEVICE FIRED? YES. WAS BUTTRESSING MATERIAL UTILIZED? NO. WERE ANY DIFFICULTIES ENCOUNTERED WHEN CLOSING ON THE TISSUE? NO. WAS THE TISSUE PIN IN PLACE PRIOR TO FIRING? YES. WAS THE INSTRUMENT FIRED ACROSS OR NEAR AN EXISTING STAPLE LINE OR CLIP? NO. WERE ANY UNEXPECTED NOISES HEARD? NO. WERE ANY OF THE FORCES HIGHER OR LOWER THAN EXPECTED (CLOSING, FIRING, OR OPENING)? NO. WAS THERE ANY DIFFICULTY REMOVING THE DEVICE FROM THE TISSUE? NO. DURING THE OPERATION, WHAT WAS THE APPEARANCE OF THE STAPLE LINE (INTACT, MALFORMED STAPLE, ETC)? INTACT. WAS PROXIMAL AND DISTAL CONTROL MAINTAINED ON THE TISSUE DURING THE FIRING SEQUENCE? YES. WAS THE STAPLE LINE INSPECTED FOR INTEGRITY PRIOR TO TRANSECTING THE TISSUE? YES. WHAT WERE THE QUALITY AND/OR THICKNESS OF THE TISSUE IN THE AREA WHERE THE DEVICE WAS FIRED? (FRIABLE, THIN, REGULAR, THICK, ETC.)? REGULAR. WAS A LEAK TEST COMPLETED? NO. IS A PATHOLOGY SPECIMEN AND/OR REPORT AVAILABLE? NO. DID THE SURGEON WAIT 15 SECONDS AFTER CLAMPING AND PRIOR TO FIRING FOR OPTIMAL COMPRESSION? YES. WAS THE FIRING TO CLOSE A SIDE BY SIDE ANASTOMOSIS? NO. WHAT WERE THE PATIENTS PRE-OP DIAGNOSIS AND/OR PRE-EXISTING CONDITIONS THAT COULD HAVE IMPACTED THE PATIENTS HEALTH/SURGICAL OUTCOME? LUNG INOSIS. WAS THERE A RECENT CONVERSION TO EES DEVICES IN THIS ACCOUNT OR WITH THIS SURGEON? NO. WHERE WAS THE LOCATION OF THE MALFORMED STAPLES ON THE ENDS OR IN THE MIDDLE OF THE STAPLE LINE? TOTALLY TWO DEVICES WERE RETURNED AND ANALYZED. DEVICE A WAS RECEIVED IN GOOD VISUAL CONDITIONS AND WITH CARTRIDGE PRESENT ON THE DEVICE. THE CARTRIDGE WAS RECEIVED VOID OF STAPLES AND WITH THE ROTATING KNOB DAMAGED. THE DEVICE WAS DISASSEMBLED TO VERIFY THE CONDITION OF THE INTERNAL COMPONENTS AND THE DEVICE WAS NOTED TO HAVE THE LOCKOUT TAB AND THE ADJUSTING KNOB DAMAGED. IN ADDITION THE ADJUSTMENT BOLT WAS BROKEN. THE DAMAGE TO THE TAB AND KNOB IS CONSISTENT WITH AN EXCESSIVE FORCE APPLIED TO THE ROTATING KNOB WHEN TRYING TO DIAL DOWN A LOCKED DEVICE, CAUSING THE DAMAGE TO THE KNOB. IT SHOULD BE NOTED THAT THE INSTRUMENT HAS BEEN DESIGNED WITH A LOCKOUT FEATURE, WHICH DURING THE FIRST APPLICATION, PREVENTS TURNING THE ADJUSTING KNOB UNLESS THE RETAINING PIN IS PUSHED COMPLETELY FORWARD. DEVICE B WAS RECEIVED IN GOOD VISUAL CONDITION. THE BREAKAWAY WASHER WAS PRESENT AND CUT AND THERE WERE NO STAPLES PRESENT, INDICATING THAT THE DEVICE ACHIEVED A FULL FIRING STROKE. THE DEVICE WAS RELOADED WITH STAPLES, A NEW WASHER WAS PLACED ON THE DEVICE AND IT WAS TESTED FOR FUNCTIONALITY. IT FIRED AND FORMED ALL THE STAPLES AS WELL AS COMPLETELY CUT THE TEST MEDIA AND THE BREAKAWAY WASHER WITHOUT INCIDENT. THE STAPLE LINE WAS COMPLETE AND THE STAPLES WERE NOTED TO HAVE THE PROPER B-FORMED SHAPE. THE MANUFACTURING RECORDS WERE REVIEWED AND NO DISCREPANCIES WERE FOUND DURING THE MANUFACTURING PROCESS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT AT THE FIRST FIRING WHEN THE DEVICE WAS USED ON THE LUNG PARENCHYMA, THE STAPLES DID NOT CLOSE. THE CASE WAS COMPLETED USING SUTURES. THERE WAS NO ADVERSE PATIENT CONSEQUENCE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    134217 PROXIMATE** RELOADABLE LINEAR STAPLER STAPLE, IMPLANTABLE GDW ETHICON ENDO-SURGERY, LLC. UNK J4AT9H

    Patients

    Seq Age Sex Outcome Treatment
    1