BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROXIMATE ILS CURVED CIR STAPL

    MDR report key: 2150708 · Received July 6, 2011

    Report

    Report Number
    3005075853-2011-02778
    Event Type
    Malfunction
    Date Received
    July 6, 2011
    Date of Event
    June 12, 2011
    Report Date
    June 15, 2011
    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
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). UNCUT WASHER - BLEMISHED. THE ANALYSIS RESULTS FOUND THAT THE DEVICE ARRIVED IN GOOD VISUAL CONDITION WITHOUT STAPLES PRESENT AND WITH THE BREAKAWAY WASHER UNCUT AND INDENTED, INDICATING THAT THE DEVICE HAD NOT BEEN FIRED THROUGH A FULL FIRING STROKE OR POSSIBLY THAT THE ORANGE INDICATOR WAS NOT FULLY INTO THE SAFE GREEN FIRING RANGE. IT SHOULD BE NOTED THAT BEFORE FIRING THE DEVICE, THE ORANGE INDICATOR SHOULD BE FULLY WITHIN THE GREEN RANGE OF THE GAP SETTING SCALE. IN ADDITION, IT SHOULD BE NOTED THAT IF THE FIRING SEQUENCE IS NOT COMPLETE (PLASTIC TO PLASTIC), STAPLES COULD BE PARTIALLY DEPLOYED WITHOUT CUTTING THE WASHER. FOR MORE INFORMATION PLEASE REFER TO THE INSTRUCTIONS FOR USE. THE DEVICE WAS RELOADED WITH STAPLES AND TESTED FOR FUNCTIONALITY WITH A TEST WASHER; THE DEVICE FORMED ALL THE STAPLES, AS WELL AS COMPLETELY CUT THE TEST MEDIA AND THE BREAKAWAY WASHER WITHOUT INCIDENT. THE STAPLE LINE WAS COMPLETE AND THE STAPLES WERE NOTED TO HAVE THE PROPER B-FORMED SHAPE. A BATCH RECORD REVIEW WAS PERFORMED AND NO ANOMALIES WERE FOUND DURING THE MANUFACTURING PROCESS.

    Additional Manufacturer Narrative · 1

    (B)(4). INFORMATION ANTICIPATED, BUT UNAVAILABLE AT THIS TIME. ADDITIONAL INFORMATION: WHAT DEVICE WAS USED FOR THE PROXIMAL AND DISTAL TRANSACTION OF THE BOWEL? WHAT COLOR RELOAD?---WE HAVE NO DETAILED INFORMATION. ON WHAT TISSUE TYPE WAS THE DEVICE USED? ---THE TISSUE WAS NOT SO THICK. 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 WAS USED. HOW WAS THE PURSE STRING PLACED, BY HAND OR WITH AN ASSIST DEVICE? IF AN ASSIST DEVICE, WHAT PRODUCT?---BY AN ASSIST DEVICE MANUFACTURED BY EES. WAS THE SPIKE OF THE TROCAR INSERTED THROUGH BOWEL LATERAL OR THROUGH THE STAPLE LINE? ---END-TO-SIDE ANASTOMOSIS. WHAT CONFIRMATION DID THE SURGEON RECEIVE THAT THE ANVIL WAS FIRMLY ATTACHED?---YES. WHEN THE DEVICE WAS FIRED, WHAT WAS THE LOCATION OF THE INDICATOR WITHIN THE GAP SETTING SCALE? ---YES. WAS BUTTRESSING MATERIAL UTILIZED? --NO. 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.)? ---WE HAVE NO DETAILED INFORMATION. WERE ANY UNEXPECTED NOISES HEARD? IF SO, WHEN? ---WE HAVE NO DETAILED INFORMATION. WERE ANY OF THE FORCES HIGHER OR LOWER THAN EXPECTED (CLOSING, FIRING, OR OPENING)? ---WE HAVE NO DETAILED INFORMATION. AFTER USE, DID THE FIRING HANDLE AUTOMATICALLY RETURN TO ITS ORIGINAL (PRE-FIRED) POSITION WITHOUT INTERVENTION? ---YES. WAS THERE ANY DIFFICULTY REMOVING THE DEVICE FROM THE TISSUE? ---NO. WHAT STEPS WERE TAKEN TO CONFIRM SUCCESSFUL ANASTOMOSIS? (SUCH AS LEAK TEST, DONUT CONFIRMATION, ETC.) ---LEAK TEST WAS PERFORMED AFTER FIRING. WHAT WERE THE INDICATIONS FOR SURGERY? WHAT WAS FOUND? ---WE HAVE NO DETAILED INFORMATION. DOES THE PATIENT HAVE ANY RELEVANT HISTORY OF SURGICAL TREATMENTS? IF SO, WHAT? ---WE HAVE NO DETAILED INFORMATION. WHAT ARE THE PATIENTS AGE AND SEX? ---WE HAVE NO DETAILED INFORMATION. DID A HCP OTHER THAN THE PRIMARY SURGEON FIRE THE INSTRUMENT? ---NO. 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 OPEN TOTAL GASTRECTOMY PROCEDURE, THE DEVICE WAS USED TO ANASTOMOSE BETWEEN THE ESOPHAGUS AND THE JEJUNUM. THE ANVIL WAS PLACED IN THE ESOPHAGUS SIDE AND THE INSTRUMENT WAS INSERTED FROM THE BLIND-ENDING OF JEJUNUM. THE SURGEON CONFIRMED THAT THE INDICATOR WAS WITHIN THE GAP SETTING SCALE AND FIRED. THE GRASPING FORCE OF THE FIRING HANDLE WAS HIGHER THAN USUAL AND THE FIRING HANDLE COULD NOT BE GRASPED COMPLETELY. ANOTHER DEVICE WAS USED TO COMPLETE THE CASE. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1