BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDOPATH** ILS ENDOSCOPIC CURVED INTRALUMINAL STAPLER - 29 MM

    MDR report key: 2071090 · Received April 27, 2011

    Report

    Report Number
    3005075853-2011-01754
    Event Type
    Injury
    Date Received
    April 27, 2011
    Date of Event
    April 10, 2011
    Report Date
    April 11, 2011
    Manufacturer
    ETHICON ENDO-SURGERY, LLC.
    Product Code
    KOG
    PMA / PMN Number
    K940967
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4)

    Additional Manufacturer Narrative · 1

    (B)(4). INFORMATION IS UNAVAILABLE; DEVICE WAS NOT RETURNED FOR EVALUATION. THE COMPLAINT COULD NOT BE CONFIRMED BECAUSE NO DEVICE WAS RETURNED FOR ANALYSIS. WE DID NOT RECEIVE A BATCH OR LOT NUMBER FOR THE PRODUCT INVOLVED IN THIS COMPLAINT. THEREFORE, WE WERE UNABLE TO CHECK MANUFACTURING RECORDS FOR ANY RELATED NON-CONFORMANCES. COMPLAINT INFORMATION IS TRENDED ON A REGULAR BASIS TO DETERMINE IF FURTHER INVESTIGATION IS WARRANTED.

    Description of Event or Problem · 1

    UNSUCCESSFUL ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION WERE COMPLETED ON (B)(4) 2011.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT FOUR DAYS POST OP OF A LAPAROSCOPIC SIGMOID PROCEDURE ON (B)(6) 2011, THE PATIENT WAS BEING PREPPED FOR RELEASE WHEN THEY DECIDED TO RETURN THE PATIENT FOR A LAST MINUTE CATSCAN ON (B)(6) 2011; FREE AIR WAS DETECTED IN THE PATIENT'S ABDOMEN. ON (B)(6) 2011, SHE WAS TAKEN TO THE OR; AN OPEN HARTMANN'S PROCEDURE WAS PERFORMED. NO ADDITIONAL INFORMATION HAS BEEN PROVIDED AT THIS TIME OTHER THAT THERE WAS NO BLEEDING AND NO BLOOD PRODUCTS ADMINISTERED TO THE PATIENT. THE PATIENT WAS NOT REQUIRED TO GO TO THE ICU UNIT AND WAS RETURNED TO HER ROOM. SHE IS BEING HELD AT THE HOSPITAL FOR OBSERVATION AND IS IN STABLE CONDITION. AN (B)(4) AND AN (B)(4) DEVICE WITH A BLUE RELOAD WERE USED DURING THE ORIGINAL CASE AND HAVE BEEN DISCARDED. THE SURGEON REPORTED THAT THIS WAS A NORMAL CASE WITH A NORMAL OUTCOME AND THEY DID NOT ENCOUNTER ANY ISSUE DURING THE ORIGINAL SURGERY. IT IS UNKNOWN WHAT WAS USED IN THE ADDITIONAL PROCEDURE AT THIS TIME.

    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 Other| R