BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ECHELON*FLEX60

    MDR report key: 3192906 · Received June 27, 2013

    Report

    Report Number
    3005075853-2013-03312
    Event Type
    Injury
    Date Received
    June 27, 2013
    Date of Event
    June 6, 2013
    Report Date
    June 7, 2013
    Manufacturer
    ETHICON ENDO-SURGERY, LLC.
    Product Code
    GDW
    PMA / PMN Number
    K081146
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). INFORMATION WAS NOT PROVIDED BY THE AFFILIATE. INFORMATION IS UNAVAILABLE; DEVICE WAS NOT RETURNED FOR EVALUATION. ATTEMPTS ARE BEING MADE TO OBTAIN THE FOLLOWING INFORMATION. TO DATE NO RESPONSE HAS BEEN PROVIDED. IF FURTHER DETAILS ARE RECEIVED AT A LATER DATE A SUPPLEMENTAL MEDWATCH WILL BE SENT. EXACT LOCATION OF THE ABSCESS? AT THE TIME OF CLOSURE WERE THERE ANY UNUSUAL ISSUES WITH THE STAPLE LINE? HOW LONG AFTER THE FIRST PROCEDURE DID THE LEAK OCCUR? WHAT COLOR CARTRIDGE WAS USED? WERE ANY DIFFICULTIES ENCOUNTERED WHEN FIRING THE DEVICE? WHAT DID STAPLE FORMATION LOOK LIKE INTRA-OP AND DURING THE RE-OP? WAS THE DEVICE SWISHED IN BETWEEN FIRINGS? WHAT WAS THE CONDITIONS OF THE PATIENTS TISSUE? PATIENTS PREEXISTING CONDITIONS? HOW IS THE PATIENT CURRENTLY? IS THE PATIENT EXPECTED TO HAVE A FULL RECOVERY? THE COMPLAINT COULD NOT BE CONFIRMED BECAUSE NO DEVICE WAS RETURNED FOR ANALYSIS. AS A LOT NUMBER WAS NOT RECEIVED, A DEVICE HISTORY REVIEW COULD NOT BE PERFORMED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT FOLLOWING A SLEEVE GASTRECTOMY PATIENTS INCURRED ¿MICRO LEAKS¿, WHICH WERE DEFINED BY THE SURGEON AS AN ABSCESS ALONG THE STAPLE LINE WITHOUT A CLEAR POINT OF WHERE THE LEAK WAS COMING FROM. THE ABSCESS CONTAINED GASTRIC CULTURES WHICH COULD ONLY EXTEND FROM A GASTRIC LEAK. PROBLEM NOTED IN THE UPPER REGION OF THE SLEEVE NEAR THE FUNDUS IN BOTH PATIENTS. THE PATIENT REQUIRED RE-ADMISSION INTO THEATRE TO DRAIN THE ABSCESSES, THE PATIENT REQUIRED 3 RETURNS TO THEATRE BEFORE THE LEAK SELF HEALED (MEANING, WITHOUT FURTHER SUTURING, STAPLING OR MEDICAL DEVICE INTERVENTION TO SEAL THE LEAK). DEVICE HAS BEEN DISCARDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    292078 ECHELON*FLEX60 STAPLE, IMPLANTABLE GDW ETHICON ENDO-SURGERY, LLC. NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention