BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROXIMATE ILS CURVED CIR STAPLER

    MDR report key: 3840373 · Received May 30, 2014

    Report

    Report Number
    3005075853-2014-03668
    Event Type
    Malfunction
    Date Received
    May 30, 2014
    Date of Event
    December 3, 2013
    Report Date
    May 24, 2014
    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
    BR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). ADDITIONAL INFORMATION WAS REQUESTED AND THE FOLLOWING WAS OBTAINED: THE FOLLOWING INFORMATION WAS REQUESTED, BUT UNAVAILABLE: THREE ATTEMPTS WERE MADE TO OBTAIN ADDITIONAL INFORMATION. TO DATE NO RESPONSE HAS BEEN PROVIDED. IF FURTHER DETAILS ARE RECEIVED AT A LATER DATE A SUPPLEMENTAL MEDWATCH WILL BE SENT. WAS THE PROCEDURE DONE OPEN/LAPAROSCOPIC? WHAT DEVICE WAS USED FOR THE PROXIMAL AND DISTAL TRANSACTION OF THE BOWEL? WHAT COLOR RELOAD? ON WHAT TISSUE TYPE WAS THE DEVICE USED? 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) HOW WAS THE PURSE STRING PLACED, BY HAND OR WITH AN ASSIST DEVICE? IF AN ASSIST DEVICE, WHAT PRODUCT? WAS THE SPIKE OF THE TROCAR INSERTED THROUGH BOWEL LATERAL OR THROUGH THE STAPLE LINE? WHAT CONFIRMATION DID THE SURGEON RECEIVE THAT THE ANVIL WAS FIRMLY ATTACHED? WHEN THE DEVICE WAS FIRED, WHAT WAS THE LOCATION OF THE INDICATOR WITHIN THE GAP SETTING SCALE? WAS BUTTRESSING MATERIAL UTILIZED? IF SO, WHICH PRODUCT? WAS THE INSTRUMENT FIRED ACROSS OR NEAR AN EXISTING STAPLE LINE OR CLIP? HOW DID YOU CONFIRM THE DEVICE WAS FULLY FIRED (SUCH AS CRUNCH, COMPRESSED UNTIL UNABLE TO FIRE FURTHER, ETC.)? WERE ANY UNEXPECTED NOISES HEARD? IF SO, WHEN? WERE ANY OF THE FORCES HIGHER OR LOWER THAN EXPECTED (CLOSING OR OPENING)? AFTER USE, DID THE FIRING HANDLE AUTOMATICALLY RETURN TO ITS ORIGINAL (PRE-FIRED) POSITION WITHOUT INTERVENTION? WAS THERE ANY DIFFICULTY REMOVING THE DEVICE FROM THE TISSUE? IF YES, HOW MANY COUNTER-CLOCKWISE REVOLUTIONS WERE USED TO OPEN THE DEVICE?

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A LOWERING OF THE COLON PROCEDURE, THE SURGEON REPORTED THAT AT THE TIME OF FIRING THE STAPLER LOCKED, LACERATING THE TISSUE. HAD TO RESECT MORE A PART OF THE TISSUE MANUALLY AND USE ANOTHER STAPLER TO MAKE ANASTOMOSIS. ANOTHER LIKE DEVICE WAS USED TO COMPLETE THE PROCEDURE. ONE DEVICE WAS DISCARDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    318397 PROXIMATE ILS CURVED CIR STAPLER STAPLE, IMPLANTABLE GDW ETHICON ENDO-SURGERY, LLC. NA K4CD0F

    Patients

    Seq Age Sex Outcome Treatment
    1