BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROXIMATE ILS CURVED CIR STAPL

    MDR report key: 2851542 · Received November 29, 2012

    Report

    Report Number
    3005075853-2012-05394
    Event Type
    Malfunction
    Date Received
    November 29, 2012
    Date of Event
    November 5, 2012
    Report Date
    November 6, 2012
    Manufacturer
    ETHICON ENDO-SURGERY, LLC.
    Product Code
    GDW
    PMA / PMN Number
    K983536
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICE WAS NOT RETURNED. ADDITIONAL INFORMATION : HOW MUCH BLOOD LOSS? NOT MUCH. HOW WAS THE PATIENT IMPACTED? NO IMPACT TO THE PATIENT CONSEQUENCE. WAS THE PROCEDURE DONE OPEN/LAPAROSCOPICALLY? OPEN. WHAT DEVICE WAS USED FOR THE PROXIMAL AND DISTAL TRANSECTION? WHAT COLOR RELOAD? KNIFE USED FOR PROXIMATE PART. LOCAL LINEAR CUTTER FOR DISTAL TRANSECTION. WHAT PURSE STRING TECHNIQUE WAS USED OR WHAT PURSE STRING TECHNIQUE DOES THIS SURGEON NORMALLY USE IN HIS/HER LEFT COLON PROCEDURES? (EX. HAND TIED PURSE STRING, PURSE STRING DEVICE) PURSE STRING DEVICE. HOW WAS THE PURSE STRING PLACED, BY HAND OR WITH AN ASSIST DEVICE? IF AN ASSIST DEVICE WAS USED, WHAT PRODUCT? BY HAND. WAS THE SPIKE OF THE TROCAR INSERTED LATERAL OR THROUGH THE STAPLE LINE? NO. WHAT CONFIRMATION DID THE SURGEON RECEIVE THAT THE ANVIL WAS FIRMLY ATTACHED? CRUNCH HEARD. WHEN THE DEVICE WAS FIRED, WHERE WAS THE INDICATOR WITHIN THE GREEN ZONE/GAP SETTING SCALE? BEHIND 1/3. WAS BUTTRESSING MATERIAL UTILIZED? IF SO, WHICH PRODUCT? YES. LOCAL HOOK. WAS THE INSTRUMENT FIRED ACROSS OR NEAR AN EXISTING STAPLE LINE OR CLIP? NO. HOW DID YOU CONFIRM THE DEVICE WAS FULLY FIRED (SUCH AS CRUNCH, COMPRESSED UNTIL UNABLE TO FIRE FURTHER, ETC.)? CRUCH. WERE ANY UNEXPECTED NOISES HEARD? IF YES, WHEN? 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.IF YES, HOW MANY COUNTER-CLOCKWISE REVOLUTIONS WERE USED TO OPEN THE DEVICE? WHAT STEPS WERE TAKEN TO CONFIRM SUCCESSFUL ANASTOMOSIS? (SUCH AS LEAK TEST, DONUT CONFIRMATION, ETC.) DONUT CONFIRMATION. DID THE OPERATION CHANGE SIGNIFICANTLY AS A RESULT OF THE DEVICE ISSUE? NO. WHAT IS THE PATIENTS AGE AND SEX? (B)(6) FEMALE. DID A HCP OTHER THAN THE PRIMARY SURGEON FIRE THE INSTRUMENT? IF SO, WHOM? HCP. WAS THERE A RECENT CONVERSION TO EES DEVICES IN THIS ACCOUNT OR WITH THIS SURGEON? NO

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE THAT THE TISSUE COULD NOT BE CLOSED COMPLETELY AFTER THE FIRING. THE SURGEON USED SWAB TO STOP BLEEDING AND USED HAND SEWING TO PIN UP THE ANASTOMOSIS TO COMPLETE THE PROCEDURE. AS THE PATIENT HAD HEPATITIS, SAMPLE HAD BEEN DISCARDED. NOW THE PATIENT IS FINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PROXIMATE ILS CURVED CIR STAPL STAPLE, IMPLANTABLE GDW ETHICON ENDO-SURGERY, LLC. UNK J4AT3L

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR Required Intervention