BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ECHELON*FLEX60 ARTICULATING

    MDR report key: 2862799 · Received December 10, 2012

    Report

    Report Number
    3005075853-2012-05513
    Event Type
    Injury
    Date Received
    December 10, 2012
    Date of Event
    September 14, 2012
    Report Date
    November 26, 2012
    Manufacturer
    ETHICON ENDO-SURGERY, LLC.
    Product Code
    GDW
    PMA / PMN Number
    K081146
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). INFORMATION IS UNAVAILABLE; DEVICE WAS NOT RETURNED FOR EVALUATION. ADDITIONAL FOLLOWUP: PER THE AFFILIATE, "ANY VISUALIZATION OF STAPLE FORMS DURING THE PROCEDURE? ---THE DOCTOR. COMMENTED THAT THE STAPLES FORMATION WAS UNKNOWN BUT THE ANASTOMOSIS SITE WAS NO PROBLEMS VISUALLY. IS IT ROUTINE TO CHECK/SCOPE A PATIENT 10 DAYS POST OP? ---WE HAVE NO DETAILED INFORMATION. WHAT LED THEM TO SCOPE THE PATIENT? ---ANASTOMOTIC DEHISCENCE. IS THERE ANYTHING THAT COULD HAVE CONTRIBUTED TO THE HEALING PROCESS? HYPERTENSION? ANY OTHER PRE-EXISTING CONDITIONS? ---NO. WHAT WAS THE PATIENT TREATED FOR AT OTHER HOSPITALS?---WE HAVE NO DETAILED INFORMATION, BUT THE DOCTOR PLANNED TO PERFORM REOPERATION IN THIS HOSPITAL. THE PATIENT'S HUSBAND WAS ANGRY AFTER THE EVENT AND THEN THE PATIENT DISCHARGED. WHAT PROCEDURE WAS PERFORMED TO ADDRESS THIS ISSUE? WHAT DEVICES WERE USED DURING THAT PROCEDURE? ---WE HAVE NO DETAILED INFORMATION WHETHER THE REOPERATION IS PERFORMED OR NOT. WAS THE PATIENT ALREADY IN THE HOSPITAL WHEN THIS OCCURRED? ---WE HAVE NO DETAILED INFORMATION. WAS THE PATIENT SCOPED AT THE ORIGINAL HOSPITAL OR SECOND HOSPITAL? ---THE ORIGINAL HOSPITAL. HOW IS THE PATIENT CURRENTLY? ---WE HAVE NO DETAILED INFORMATION. IS THE PATIENT EXPECTED TO HAVE A FULL RECOVERY? ---WE HAVE NO DETAILED INFORMATION. ON WHAT TISSUE TYPE WAS THE DEVICE USED? AT WHAT LOCATION ON THE TISSUE?---NORMAL. WAS THE DEVICE FIRED ON TISSUE THAT HAD BEEN RADIATED OR HAS THE PATIENT BEEN TAKING SYSTEMIC STEROIDS? ---WE HAVE NO DETAILED INFORMATION. ON WHICH FIRING(S) DID THIS EVENT OCCUR (1ST, 2ND, 12TH, ETC)? ---WE HAVE NO DETAILED INFORMATION. WHAT OTHER COLOR CARTRIDGES WERE USED BEFORE AND AFTER THIS EVENT? ---WE HAVE NO DETAILED INFORMATION. WAS BUTTRESSING MATERIAL UTILIZED? IF SO, WHICH PRODUCT? ---NO. WAS THE INSTRUMENT FIRED ACROSS OR NEAR AN EXISTING STAPLE LINE OR CLIP? ---NO. WERE ANY UNEXPECTED NOISES HEARD? IF SO, WHEN? ---NO. 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. WAS THERE ANY DIFFICULTY REMOVING THE DEVICE FROM THE TISSUE? ---NO. WHAT WERE THE PATIENT'S PRE-EXISTING CONDITIONS? ---CANCER OF RECTUM. DOES THE PATIENT HAVE ANY RELEVANT HISTORY OF SURGICAL TREATMENTS? IF SO, WHAT? ---WE HAVE NO DETAILED INFORMATION. HOW LONG HAS THE SURGEON BEEN USING THIS DEVICE FOR THIS PROCEDURE (IN YEARS)? ---WE HAVE NO DETAILED INFORMATION. WERE THERE ANY MALFORMED STAPLES NOTICED? ---NO".

    Description of Event or Problem · 1

    IT WAS REPORTED THAT ABOUT 10 DAYS AFTER A LAPAROSCOPIC LOW ANTERIOR RESECTION, IT WAS FOUND THAT THE ANASTOMOSIS SITE WAS OPENED. WHEN THE CAMERA WAS INSERTED IN THE PATIENT VIA THE ANUS, THE CAMERA GOT TO THE CAVITAS PELVIS. THE GRANULATION ON THE CUT END OF THE GUT TRACT WHICH WAS ANASTOMOSIS SITE OF THE ORAL SIDE WAS CONFIRMED. NO STOOL ESCAPED INTO THE ABDOMINAL CAVITY SINCE THE COVERING STOMA WAS PLACED. IN THE FORMER OPERATION, THE TARGET TISSUE WAS ANASTOMOSIS AS DOUBLE STAPLING TECHNIQUE WITH CIRCULAR STAPLER AND ENDOCUTTER LOADING A GOLD CARTRIDGE. THE ANASTOMOSIS SITE WAS ABOUT 2CM AWAY FROM THE DENTATE LINE. THE STAPLE LINE WAS CONFIRMED PROPERLY ON X-RAY AFTER THE FORMER PROCEDURE. THE PATIENT IS (B)(6) FEMALE. SHE HAS NO RISK FACTOR LIKE DIABETES OR OBESITY. SHE HAD ALREADY DISCHARGED FROM THE HOSPITAL AND WILL BE RECEIVED TREATMENT AT OTHER HOSPITAL. ANOTHER DEVICE WAS USED TO COMPLETE THE CASE. NO DEVICE WILL BE RETURNING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ECHELON*FLEX60 ARTICULATING STAPLE, IMPLANTABLE GDW ETHICON ENDO-SURGERY, LLC. NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention ECR60D (DISCARDED)