BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROXIMATE LINEAR STAPLER

    MDR report key: 4031100 · Received August 22, 2014

    Report

    Report Number
    3005075853-2014-05890
    Event Type
    Malfunction
    Date Received
    August 22, 2014
    Date of Event
    August 14, 2014
    Report Date
    August 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
    SF
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). INFORMATION IS UNAVAILABLE; DEVICE WAS NOT RETURNED FOR EVALUATION. TO DATE THE DEVICE HAS NOT BEEN RETURNED. IF FURTHER DETAILS ARE RECEIVED AND/OR DEVICE IS RECEIVED AND ANALYZED, A SUPPLEMENTAL MEDWATCH REPORT WILL BE SENT. AT THE TIME OF THIS SUBMISSION, THE DEVICE HAS NOT BEEN RETURNED FOR ANALYSIS.

    Additional Manufacturer Narrative · 1

    (B)(4). ADDITIONAL INFORMATION: ADDITIONAL INFORMATION WAS REQUESTED AND THE FOLLOWING WAS OBTAINED: WAS THE TISSUE EXCISED PRIOR TO CHECKING THE STAPLE LINE? YES AND NO. WHEN DOING THIS PROCEDURE AND STAPLING AS FAR DOWN AS THE 1-2 CM ABOVE THE DENTATE LINE IT IS IMPOSSIBLE TO SEE THE DISTAL STAPLE LINE. AFTER FIRING WHEN THE TISSUE IS CUT AND RELEASED IT RETRACTS AND THEREFORE IMPOSSIBLE TO SEE FROM ABOVE. THE PROXIMAL STAPLE LINE WAS CHECKED AND WAS CONFIRMED AS PERFECT. WERE THERE STAPLES SEEN IN THE SURGICAL FIELD? DEFINITELY NOT. THE SGN CHECKED VERY CAREFULLY FOR THEM. THERE WERE NO REMAINING STAPLES IN THE RELOAD EITHER. THE COLORED STAPLE DRIVERS IN THE RELOADS WERE VISIBLE, SHOWING THAT BOTH RELOADS HAD COMPLETED THEIR FIRING STROKE. HOW LONG WAS THE PROCEDURE EXTENDED (MINUTES)? THE PROCEDURE WAS EXTENDED BY 210 MINUTES (3 ½ HOURS). DID THE POST-OPERATIVE CARE CHANGE? IF YES, PLEASE EXPLAIN. POST-OPERATIVE CARE DID NOT CHANGE. POST-OPERATIVE FUNCTION WILL ONLY BE CONFIRMED ONCE THE COVERING ILEOSTOMY IS REVERSED AND CONTINENCE IS NOTED. WAS THE CDH29A USED IN THE PROCEDURE OR DID THE SURGEON GO DIRECTLY TO SUTURING? THE CDH29A WAS NOT FIRED. THE ANVIL WAS HOWEVER INSERTED PROXIMALLY, BUT ONCE THE SGN CONFIRMED THE ABSENCE OF THE DISTAL STAPLE LINE AFTER DIGITAL EXAMINATION THE CDH29A WAS NOT INTRODUCED TRANS-ANALLY. A HAND ANASTOMOSIS WAS EVENTUALLY DONE TRANS-ANALLY TO REJOIN THE POUCH TO THE ANUS. ADDITIONAL INFORMATION REQUESTED: WERE SIZERS USED? IF YES, WHEN? WHAT PURSE STRING TECHNIQUE WAS USED? WHAT WAS THE CONDITION OF THE TISSUE? WERE THERE ANY ADDITIONAL ADVERSE CONSEQUENCES DUE TO THE EXTENDED STAY IN THE OR? WERE ANY STAPLES NOTED IN THE DISTAL SURGERY LINE? WAS THERE ANY PRIOR CHEMO/RADIATION TREATMENT? WHAT WERE THE INDICATIONS FOR THE DISTAL ANAL TRANSECTION?

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING AN OLEO-ANAL ANASTOMOSIS PROCEDURE, THE SURGEON WAS PERFORMING THE PROCEDURE AND THE DEVICE WAS INITIALLY FIRED FOR THE DISTAL STAPLE LINE, THEN RELOADED AND FIRED AGAIN FOR THE PROXIMAL STAPLE LINE. THE PROXIMAL ANASTOMOSIS WAS INSPECTED AND THE STAPLES WERE INTACT. THE ASSISTANT THEN INTRODUCED THE CDH29A TRANS-ANALLY TO COMPLETE THE ANASTOMOSIS. THE ASSISTANT DID NOT FEEL THE DISTAL STAPLE LINE SO IT IS ASSUMED THAT THE INITIAL FIRING OF THE GUN WAS FAULTY. THE PROCEDURE WAS APPARENTLY COMPLETED BY HAND ANASTOMOSIS AND EXTENDED THE THEATRE TIME OF THE PROCEDURE BY SEVERAL HOURS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    508939 PROXIMATE LINEAR STAPLER STAPLE, IMPLANTABLE GDW ETHICON ENDO-SURGERY, LLC. NA K4CU6E

    Patients

    Seq Age Sex Outcome Treatment
    1 RELOAD-XR30G