BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROXIMATE ILS CURVED CIR STAPL

    MDR report key: 2820775 · Received November 6, 2012

    Report

    Report Number
    3005075853-2012-05028
    Event Type
    Malfunction
    Date Received
    November 6, 2012
    Date of Event
    October 24, 2012
    Report Date
    October 24, 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 ANALYSIS RESULTS FOUND THAT THE DEVICE ARRIVED IN GOOD VISUAL CONDITION VOID OF STAPLES AND WITH THE BREAKAWAY WASHER UNCUT, INDICATING THAT THE DEVICE HAD NOT BEEN FIRED THROUGH A FULL FIRING STROKE, THE ORANGE INDICATOR WAS NOT FULLY INTO THE SAFE GREEN FIRING RANGE OR THE ANVIL WAS NOT REATTACHED CORRECTLY. BEFORE FIRING, THE ORANGE INDICATOR NEEDS TO BE FULLY WITHIN THE GREEN RANGE OF THE GAP SETTING SCALE AND THE ANVIL IS REATTACHED CORRECTLY. IF THE ANVIL IS NOT ATTACHED CORRECTLY OR THE ORANGE INDICATOR NOT BEING SET ON THE GREEN RANGE WILL RESULT IN A BIGGER GAP BETWEEN THE ANVIL AND THE GUIDE FACE, THEREFORE, THE STAPLES WILL NOT HIT THE ANVIL TO MAKE B- FORMED STAPLES. IN ADDITION, IF THE FIRING SEQUENCE IS NOT COMPLETE, STAPLES COULD BE PARTIALLY DEPLOYED WITHOUT CUTTING THE WASHER. THE DEVICE WAS RELOADED WITH STAPLES AND TESTED FOR FUNCTIONALITY; 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. THE MANUFACTURING RECORDS WERE REVIEWED AND NO ANOMALIES WERE FOUND DURING THE MANUFACTURING PROCESS.

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4). WAS THE PROCEDURE DONE OPEN/LAPAROSCOPIC? OPEN. WHAT DEVICE WAS USED FOR THE PROXIMAL AND DISTAL TRANSACTION OF THE BOWEL? KNIFE USED FOR THE PROXIMAL TRANSECTION AND ECHELON FLEX FOR DISTAL TRANSACTION WITH GOLD RELOAD UNIT. ON WHAT TISSUE TYPE WAS THE DEVICE USED? RECTUM. WHAT PURSE STRING TECHNIQUE WAS USED OR WHAT PURSE STRING TECHNIQUE DOES THIS SURGEON NORMALLY USE IN HIS/HER LEFT COLON PROCEDURES? PURSE STRING DEVICE. HOW WAS THE PURSE STRING PLACED? HAND. WAS THE SPIKE OF THE TROCAR INSERTED THROUGH BOWEL LATERAL OR THROUGH THE STAPLE LINE? LATERAL. WHAT CONFIRMATION DID THE SURGEON RECEIVE THAT THE ANVIL WAS FIRMLY ATTACHED? CRUNCH HEARD. WHEN THE DEVICE WAS FIRED, WHAT WAS THE LOCATION OF THE INDICATOR WITHIN THE GAP SETTING SCALE? BEHIND 2/3 OF GREEN AREA. WAS BUTTRESSING MATERIAL UTILIZED?UNK. WAS THE INSTRUMENT FIRED ACROSS OR NEAR AN EXISTING STAPLE LINE OR CLIP? NEAR. HOW DID YOU CONFIRM THE DEVICE WAS FULLY FIRED (SUCH AS CRUNCH, COMPRESSED UNTIL UNABLE TO FIRE FURTHER, ETC.)? COMPRESSED UNTIL UNABLE TO FIRE FURTHER. WERE ANY UNEXPECTED NOISES HEARD? NO. WERE ANY OF THE FORCES HIGHER OR LOWER THAN EXPECTED (CLOSING, FIRING, OR OPENING)? NO. 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? IF YES, HOW MANY COUNTER-CLOCKWISE REVOLUTIONS WERE USED TO OPEN THE DEVICE? UNK. WHAT STEPS WERE TAKEN TO CONFIRM SUCCESSFUL ANASTOMOSIS? DONUT CONFIRMATION. IS THERE ANY OTHER ADDITIONAL INFORMATION YOU WOULD LIKE TO SHARE ABOUT THIS DEVICE, PROCEDURE, PATIENT OR PHYSICIAN? UNK. WHAT WERE THE INDICATIONS FOR SURGERY? UNK. DOES THE PATIENT HAVE ANY RELEVANT HISTORY OF SURGICAL TREATMENTS? UNK. DID A HCP OTHER THAN THE PRIMARY SURGEON FIRE THE INSTRUMENT? PRIMARY SURGEON. 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, THE STAPLES IN THE DISTAL PART AND PROXIMAL PART WERE MALFORMED AFTER THE FIRING. THE SURGEON CHANGED ANOTHER ONE TO COMPLETE THE PROCEDURE. NO ADVERSE EVENT ON THE PATIENT.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION PROVIDED.

    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 42 YR