BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ROTATING MULTIPLE CLIP APPLIER

    MDR report key: 2251643 · Received September 16, 2011

    Report

    Report Number
    3005075853-2011-03831
    Event Type
    Injury
    Date Received
    September 16, 2011
    Report Date
    August 25, 2011
    Manufacturer
    ETHICON ENDO-SURGERY, LLC.
    Product Code
    FZP
    PMA / PMN Number
    K864102
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SD, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). INFORMATION IS UNAVAILABLE; DEVICE WAS NOT RETURNED FOR EVALUATION. CLINICAL CONVERSATION TOOK PLACE WITH THE SURGEON AND EES MEDICAL CONSULTANT ON (B)(6) 2011. THE FOLLOWING SUMMARY WAS PROVIDED BY THE EES MEDICAL CONSULTANT: "I SPOKE WITH THE SURGEON REGARDING THIS COMPLAINT ALONG WITH THE EES LIFE CYCLE ENGINEER. HE WAS HAPPY TO SPEAK WITH US. THE SURGEON IS AN EXPERIENCED SURGEON (B)(6). SINCE ARRIVING AT HIS CURRENT (B)(6), HE HAS PERFORMED 10 LAPAROSCOPIC CHOLECYSTECTOMIES, AND ONE OPEN CHOLECYSTECTOMY FOR GANGRENOUS CHOLECYSTITIS. THE SURGEON ASSURED ME THAT THE INSTRUMENT HANDLED AS EXPECTED WITH NO UNTOWARD EVENTS IN THE HANDLING OR FIRING OF THE DEVICE. HE WAS ABLE TO ADEQUATELY EVALUATE THE POSITION AND SHAPE OF THE CLIPS AFTER THEIR BEING SET. AT NO TIME DID HE FEEL THERE WAS A NEED FOR ADDITIONAL MANEUVERS TO DEAL WITH POORLY FORMED CLIPS. AS NOTED IN THE EVENT DESCRIPTION THE PATIENT DEVELOPED POST-OP BILE LEAK SYMPTOMS, WERE WORKED-UP WITH CT SCAN AND HAD ERCP PERFORMED TO DIAGNOSE THE LEAK AND CONTROL THE LEAK WITH STENTS. THE PATIENT IS NOW DOING WELL. THE SURGEON DID NOT PERFORM INTRA-OPERATIVE CHOLANGIOGRAMS ON THIS PATIENT AS THEY WERE NOT INDICATED BY PRE-OPERATIVE LABS OR IMAGING. HE COULD NOT TELL ME IF DURING ERCP OR RE-OPERATION, IF THE CLIPS WERE SEEN TO BE PRESENT ON THE CYSTIC DUCT STUMP, OR THE NATURE OF THOSE CLIPS IF PRESENT. THE SURGEON HAS BEEN SUSPENDED FROM PERFORMING SURGERY." THE SURGEON INITIALLY REPORTED THE ACCOUNT WOULD BE SENDING BACK STERILE PRODUCT FOR ANALYSIS; HOWEVER, WHEN THE HOSPITAL WAS CONTACTED TO COORDINATE THE RETURN OF THE PRODUCT, THE HOSPITAL INDICATED THEY WILL NOT BE RETURNING THE STERILE PRODUCT AS THE OTHER PHYSICIAN IS CONTINUING TO USE THE PRODUCT. ADDITIONAL CLINICAL AND ENGINEERING SUPPORT WAS OFFERED TO THE SURGEON. TO DATE, NO RESPONSE HAS BEEN RECEIVED. IF FURTHER DETAILS BECOME AVAILABLE AT A LATER DATE, A SUPPLEMENTAL MEDWATCH WILL BE SENT TO REFLECT ANY NEW INFORMATION. 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 DURING A LAPAROSCOPIC CHOLECYSTECTOMY PROCEDURE THE CASE WENT WELL. THE NEXT DAY THE PATIENT PRESENTED WITH A POST-OP LEAK. AN ERCP, LEAK TEST WAS PERFORMED AND IT WAS NOTICED THAT THE CYSTIC DUCT REMNANT WAS LEAKING. THE SURGEON PLACED A STENT AT THE LEAK SITE FOR DRAINAGE. FOUR TO SIX WEEKS LATER THE DUCT WAS CLOSED .

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ROTATING MULTIPLE CLIP APPLIER CLIP, IMPLANTABLE FZP ETHICON ENDO-SURGERY, LLC. NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention