BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDOPATH** ETS45

    MDR report key: 3010783 · Received March 19, 2013

    Report

    Report Number
    3005075853-2013-01275
    Event Type
    Injury
    Date Received
    March 19, 2013
    Date of Event
    February 21, 2013
    Report Date
    February 22, 2013
    Manufacturer
    ETHICON ENDO-SURGERY, LLC.
    Product Code
    GDW
    PMA / PMN Number
    K020779
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE ANALYSIS RESULTS FOUND THAT THE ETS45 DEVICE WAS RECEIVED WITH THE CLAMPING MECHANISM DAMAGED AND WITH A RELOAD LOADED IN THE DEVICE. THE RELOAD WAS RECEIVED FULLY FIRED AND WITH THE LOCKOUT SPRING NORMAL. THE DEVICE WAS DISASSEMBLED TO VERIFY THE CONDITION OF THE INTERNAL COMPONENTS AND THE YOKE WAS FOUND DAMAGED WHERE ENGAGES WITH THE TUBE (YOKE FLANGE). PLEASE NOTE THAT AN INVESTIGATION HAS BEEN INITIATED TO ADDRESS THE POTENTIAL ROOT CAUSE FOR THE DAMAGE OF THE YOKE FLANGE.

    Additional Manufacturer Narrative · 1

    (B)(4). DEVICE WAS NOT RETURNED FOR EVALUATION. ON WHAT TISSUE TYPE WAS THE DEVICE USED? LUNG AT WHAT LOCATION ON THE TISSUE? THE BULLA. WAS IT USED ON THICK TISSUE? NO. DID THE SURGEON WAITED THE RECOMMENDED 15 SECONDS AFTER CLOSING AND BEFORE FIRING THE DEVICE? YES. ON WHICH FIRING(S) DID THIS EVENT OCCUR (1ST, 2ND, 8TH, ETC.) 3RD. WHAT COLOR CARTRIDGE WAS BEING USED? GREEN. WAS BUTTRESSING MATERIAL UTILIZED? NO IF SO, WHICH PRODUCT? N/A. WAS THE INSTRUMENT FIRED ACROSS OR NEAR AN EXISTING STAPLE LINE OR CLIP? NO CLIPS, IT WAS A CONTINUOUS STAPLE LINE TRANSACTION FOR A LARGE AREA OF TISSUE. WERE ANY UNEXPECTED NOISES HEARD? NO IF SO, WHEN? N/A. WERE ANY OF THE FORCES HIGHER OR LOWER THAN EXPECTED (CLOSING, FIRING, OR OPENING)? NO. AFTER USE, DID EACH OF THE TRIGGERS AND BUTTONS AUTOMATICALLY RETURN TO THEIR ORIGINAL (PRE-FIRED) POSITIONS, WITHOUT INTERVENTION? YES, SOMETIMES THE HANDLES HAVE TO BE MANUALLY PUSHED OPEN. "UPON FIRING THE THIRD RELOAD THE JAWS WOULD NOT OPEN FROM THE TISSUE." WAS THE DEVICE STILL ARTICULATED AT THIS STEP? NO - THIS DEVICE DOES NOT ARTICULATE HAS ADDITIONAL TISSUE TO BE CUT OUT? IF YES, PLEASE SPECIFY THE AMOUNT OF ADDITIONAL TISSUE IN CM, OR WAS THIS TISSUE INTENDED TO BE CUT AWAY ANYWAY? YES 1 TO 2CM EXTRA LUNG TISSUE HAD TO BE TAKEN OUT. HAS THIS ANY IMPACT ON THE PATIENT, THE SURGERY OR THE HEALING PROCESS? THE PATIENT HAD A PROTRACTED AIR LEAK AND HAD TO STAY IN HOSPITAL FOR 12 DAYS (NORMALLY ONLY 2-3 DAYS STAY). IS IT POSSIBLE TO SAY WHAT THE STROKE COUNT INDICATOR DISPLAYS AT THE TIME THE DEVICE COULDN'T BE OPENED? NOT AVAILABLE ON THIS DEVICE WHAT POSITION DID THE KNIFE BLADE INDICATOR SHOW? NOT AVAILABLE ON THIS DEVICE. WHAT WAS THE PATIENT'S PRE-OP DIAGNOSIS? BACKGROUND BULLOUS DISEASE. PLEASE PROVIDE THE PATIENT'S SEX, AGE AND WEIGHT. F, (B)(6), SLIM WHAT IS THE CURRENT STATUS OF THE PATIENT? PATIENT WAS DISCHARGED ON DAY 12 IS THERE ANY OTHER ADDITIONAL INFORMATION YOU WOULD LIKE TO SHARE ABOUT THIS DEVICE OR PROCEDURE? NO VISUAL INSPECTION OF THE DEVICE REVEALED THAT THE DEVICE AND THE JAWS ARE LOCKED CLOSED WITH TISSUE VISIBLE IN THE CLOSED JAWS. BOTH THE CLOSING AND FIRING HANDLES ARE IN THE OPEN POSITION. THE HOSPITAL HAS QUARANTINED ALL DEVICES AND RELOADS FROM THE SAME LOTS UNTIL AN INVESTIGATION HAS BEEN CARRIED OUT AND WILL NOT RELEASE THE DEVICE FOR EVALUATION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A WEDGE RESECTION PROCEDURE THE SURGEON HAD FIRED TWO GREEN RELOADS WITH NO PROBLEMS. UPON FIRING THE THIRD RELOAD THE JAWS WOULD NOT OPEN FROM THE TISSUE. THE SURGEON HAD TO OPEN ANOTHER INSTRUMENT AND FIRE PAST THE JAMMED DEVICE, SO THAT COULD BE REMOVED FROM THE LUNG. A LARGER SECTION OF LUNG TISSUE THAN WAS NECESSARY HAD TO BE RESECTED BECAUSE THE DEVICE COULD NOT BE REMOVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    114648 ENDOPATH** ETS45 STAPLE, IMPLANTABLE GDW ETHICON ENDO-SURGERY, LLC. UNK J4CR94

    Patients

    Seq Age Sex Outcome Treatment
    1 35 YR Required Intervention TR45G