BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    3005075853-2010-04779

    MDR report key: 1811554 · Received August 23, 2010

    Report

    Report Number
    3005075853-2010-04779
    Event Type
    Malfunction
    Date Received
    August 23, 2010
    Date of Event
    July 15, 2010
    Report Date
    July 26, 2010
    Manufacturer
    ETHICON ENDO-SURGERY, LLC.
    Product Code
    GCJ
    PMA / PMN Number
    K032676
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MT, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). DEVICE NOT RETURNED.

    Additional Manufacturer Narrative · 1

    (B)(4). DATE SENT: 08/23/2010. INFORMATION WAS NOT PROVIDED BY THE INITIAL CONTACT. INFORMATION ANTICIPATED, BUT UNAVAILABLE AT THIS TIME. (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4). AN EES R&D ASSOCIATE AND AN EES MARKETING ASSOCIATE COMPLETED AN ONSITE VISIT TO DISCUSS THE ACCOUNT'S RECENT LEAKING ISSUES. DURING THE VISIT, FUTURE DEVICE ENHANCEMENTS WERE DISCUSSED. IT SHOULD BE NOTED THAT AN INVESTIGATION HAS BEEN INITIATED TO DETERMINE POTENTIAL ROOT CAUSE AND DEVICE ENHANCEMENTS.

    Description of Event or Problem · 1

    .

    Description of Event or Problem · 1

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A RESOLUTION CLIP DEVICE WAS USED DURING A COLONOSCOPY PERFORMED ON (B)(6) 2010. ACCORDING TO THE COMPLAINANT, THEY WERE PLACING A CLIP FOR A POST POLYPECTOMY. DURING THE PROCEDURE, THE CLIP GRASPED ONTO TISSUE HOWEVER; THE CLIP WOULD NOT RELEASE FROM THE CATHETER. IT WAS REPORTED THAT THE CLIP WAS PULLED OFF THE TISSUE AND REMOVED FROM THE PATIENT WITHOUT ANY TISSUE DAMAGE. THE CASE WAS COMPLETED WITH ANOTHER RESOLUTION CLIP DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. THE PATIENT'S CONDITION AT THE CONCLUSION OF THE PROCEDURE WAS REPORTED TO BE STABLE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A LAPAROSCOPIC CHOLECYSTECTOMY PROCEDURE, THE TROCAR WAS LEAKING. UNKNOWN HOW THE CASE WAS COMPLETED. THERE WAS NO PATIENT CONSEQUENCE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 GCJ ETHICON ENDO-SURGERY, LLC.

    Patients

    Seq Age Sex Outcome Treatment
    1