BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDOPATH** ILS ENDOSCOPIC CURVED INTRALUMINAL STAPLER - 29 MM

    MDR report key: 1974007 · Received January 31, 2011

    Report

    Report Number
    3005075853-2011-00351
    Event Type
    Injury
    Date Received
    January 31, 2011
    Date of Event
    January 8, 2011
    Report Date
    January 10, 2011
    Manufacturer
    ETHICON ENDO-SURGERY, LLC.
    Product Code
    KOG
    PMA / PMN Number
    K940967
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AR, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). INFORMATION ANTICIPATED, BUT UNAVAILABLE AT THIS TIME. ADDITIONAL INFORMATION: PRIOR TO SURGERY, IT WAS NOT DETERMINED IF THE PATIENT WAS TO RECEIVE A TEMPORARY OR PERMANENT COLOSTOMY. THE SURGEON MENTIONED THAT THE PATIENT WAS AN ELDERLY PATIENT AND NOT ABLE TO BE WELL PREPPED. LATER IT WAS REPORTED THAT THE SURGEON WHO FIRED THE DEVICE MENTIONED THAT AFTER FIRING THE DEVICE, SHE DID THE 3/4 TURN AND FISH TAILED THE DEVICE OUT; IT WAS DIFFICULT TO REMOVE THE DEVICE. SHE IS STILL PUZZLED AS TO WHY THE DONUTS WERE COMPLETE EVEN THOUGH THERE WAS A HOLE AND NOT ALL THE STAPLES FORMED.

    Additional Manufacturer Narrative · 1

    (B)(4). ANVIL_NOT RETURNED AND MISSING WASHER THE ANALYSIS RESULTS FOUND THAT THE DEVICE ARRIVED WITH THE ANVIL MISSING, OTHERWISE IN GOOD VISUAL CONDITION. AS THE ORIGINAL ANVIL WAS NOT RECEIVED, FURTHER INVESTIGATION WITH THE ORIGINAL ANVIL COULD NOT BE PERFORMED. THE BREAKAWAY WASHER WAS NOT PRESENT AND THERE WERE NO STAPLES PRESENT. THE DEVICE WAS RELOADED WITH STAPLES, A NEW WASHER WAS PLACED ON THE DEVICE AND IT WAS TESTED FOR FUNCTIONALITY WITH A TEST ANVIL; IT FIRED AND 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. EVENT COULD NOT BE CONFIRMED AS NO ANVIL WAS RECEIVED FOR ANALYSIS. IT SHOULD BE NOTED THAT WHEN REMOVING THE DEVICE, OPEN THE INSTRUMENT BY TURNING THE ADJUSTING KNOB COUNTERCLOCKWISE. FOR EASY REMOVAL, ONLY OPEN THE INSTRUMENT ONE-HALF TO THREE-FOURTHS REVOLUTIONS. TO ASSURE THE ANVIL IS FREE FROM TISSUE, ROTATE THE INSTRUMENT 90° IN BOTH DIRECTIONS. TO WITHDRAW THE OPEN INSTRUMENT, GENTLY APPLY REARWARD TRACTION WHILE SIMULTANEOUSLY ROTATING. PLEASE REFERENCE INSTRUCTIONS FOR USE FOR ADDITIONAL INFORMATION NEEDED. A BATCH RECORD REVIEW WAS PERFORMED AND NO ANOMALIES WERE FOUND DURING THE MANUFACTURING PROCESS.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION WAS REQUESTED ON (B)(6) 2011 AND NO INFORMATION WAS RECEIVED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A SIGMOID COLON RESECTION PROCEDURE, THE SURGEON WAS HOOKING THE PROXIMAL AND DISTAL BOWEL. WHEN THE DEVICE WAS FIRED, A CRUNCH WAS HEARD. HOWEVER, THE DEVICE WAS TURNED 90 DEGREES TO THE RIGHT THEN TO THE LEFT AND IT IS UNSURE WHAT HAPPENED WHEN THE DEVICE WAS TURNED TO THE LEFT. WHEN THE DEVICE WAS REMOVED, THE SURGEON LOOKED AT THE ANASTOMOSIS SITE AND THERE WAS A HOLE AND HALF THE STAPLES WERE CRIMPED WRONG NOT IN THE B FORM. THE DEVICE WAS DIFFICULT TO REMOVE. THE PATIENT RECEIVED A PERMANENT COLOSTOMY. THE PATIENT IS CURRENTLY IN THE INTENSIVE CARE UNIT. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ENDOPATH** ILS ENDOSCOPIC CURVED INTRALUMINAL STAPLER - 29 MM CIRCULAR STAPLERS KOG ETHICON ENDO-SURGERY, LLC. NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 79 YR Other| R