BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ECHELON LINEAR CUTTER RELOAD

    MDR report key: 3841514 · Received May 30, 2014

    Report

    Report Number
    3005075853-2014-03688
    Event Type
    Injury
    Date Received
    May 30, 2014
    Date of Event
    May 8, 2014
    Report Date
    May 9, 2014
    Manufacturer
    ETHICON ENDO-SURGERY, LLC.
    Product Code
    GDW
    PMA / PMN Number
    K051002
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PO
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). DEVICE WAS NOT RETURNED FOR EVALUATION. ADDITIONAL INFORMATION WAS REQUESTED AND THE FOLLOWING WAS OBTAINED: DID THE SURGEON OR ANYONE ELSE MENTIONED DIFFICULTIES WITH THE DEVICE DURING THAT SURGERY? - NO. DID THE SURGEON STARTED THE WEDGE RESECTION IN LAPAROSCOPIC TECHNIQUE? BECAUSE AT THE EVENT DESCRIPTION ¿PROCEDURE WAS CONVERTED TO OPEN¿ IS MENTIONED. - SIM. WAS THE CONVERSION TO AN OPEN PROCEDURE ONLY CAUSED BY THE DIFFICULTIES WITH THE DEVICE? - YES. ON WHAT TISSUE TYPE WAS THE DEVICE USED? AT WHAT LOCATION ON THE TISSUE? WAS IT A WEDGE RESECTION ON THE LUNG OR LIVER? ¿ RESECTION ON THE LUNG. WAS IT USED ON THICK TISSUE? - MEDIUM TISSUE, USUALLY WHEN USED BLUE CARTIDGE. ON WHICH FIRING(S) DID THIS EVENT OCCUR (1ST, 2ND, 3RD OR 4TH)? DURING WHICH STROKE DID THE EVENT OCCUR? - WAS BUTTRESSING MATERIAL UTILIZED? IF SO, WHICH PRODUCT? WAS THE INSTRUMENT FIRED ACROSS OR NEAR AN EXISTING STAPLE LINE OR CLIP? - WERE ANY UNEXPECTED NOISES HEARD? IF SO, WHEN? - WERE ANY OF THE FORCES HIGHER OR LOWER THAN EXPECTED (CLOSING, FIRING, OR OPENING)? AFTER USE, DID EACH OF THE TRIGGERS AND BUTTONS AUTOMATICALLY RETURN TO THEIR ORIGINAL (PRE-FIRED) POSITIONS, WITHOUT INTERVENTION? WAS THERE ANY DIFFICULTY REMOVING THE DEVICE FROM THE TISSUE? IS THERE ANY OTHER ADDITIONAL INFORMATION YOU WOULD LIKE TO SHARE ABOUT THIS DEVICE OR PROCEDURE? - NO. WAS THE DEVICE FULLY ARTICULATED? DEGREE OF ARTICULATION? WHAT WAS THE OUTCOME, LEAKAGE, BLEEDING OR OTHER PLEASE SPECIFY? ¿ STAPLE LINE OPEN. DID THE SURGEON WAITED THE RECOMMENDED 15 SECONDS AFTER CLOSING AND BEFORE FIRING THE DEVICE? - YES WAS THE CARTRIDGE CORRECT INSERTED, DID THEY HEAR THE ¿CLICK¿? - YES. ¿IN THE OPENING OF THE STAPLE LINE¿ WHICH PART OF THE STAPLE LINE? PROXIMAL, DISTAL OR COMPLETE? STAPLE FORMATION? WAS THE ADDITIONAL PROCEDURE TIME ONLY CAUSED BY THE DIFFICULTIES WITH THE DEVICE? OR WERE THERE OTHER CIRCUMSTANCES, PATIENT CONDITIONS OR SURGEON¿S PREFERENCES THAT MAY HAVE CAUSE THE ADDITIONAL TIME? HAS THIS ANY IMPACT ON THE PATIENT, THE SURGERY OR THE HEALING PROCESS? - NO. WHAT WAS THE OUTCOME, LEAKAGE, BLEEDING OR OTHER PLEASE SPECIFY? WHAT IS THE AGE AND SEX OF THE PATIENT? WHAT IS THE CURRENT STATUS OF THE PATIENT? ¿ GOOD.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A WEDGE RESECTION PROCEDURE, THE DOCTOR USED AN ENDOCUTTER AND FOUR BLUE RELOADS. ONE OF THE BLUE RELOADS WAS NOT STAPLING CORRECTLY RESULTING IN THE OPENING OF THE STAPLE LINE. THE PROCEDURE WAS CONVERTED TO OPEN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    318156 ECHELON LINEAR CUTTER RELOAD STAPLE, IMPLANTABLE GDW ETHICON ENDO-SURGERY, LLC. NA L4E399

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention DEVICE - EC60A