BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VALUTRUS LC HANDLE

    MDR report key: 5149918 · Received October 14, 2015

    Report

    Report Number
    1527736-2015-00022
    Event Type
    Malfunction
    Date Received
    October 14, 2015
    Date of Event
    August 19, 2015
    Report Date
    August 20, 2015
    Manufacturer
    ETHICON ENDO SURGERY, INC (CINCINNATI)
    Product Code
    ODC
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). INFORMATION WAS NOT PROVIDED BY THE CONTACT. BATCH # 111364. ADDITIONAL INFORMATION WAS REQUESTED AND THE FOLLOWING WAS OBTAINED: THE LOT NUMBER THAT WAS PROVIDED IS INVALID FOR THE PRODUCT CODE. PLEASE CONFIRM. LOT NO :111364. HOW WAS THE PROCEDURE COMPLETED? SURGEON HAS DONE HAND ANASTOMOSIS. DID ANY PIECES FALL INTO THE PATIENT? NO. IF YES, WERE THEY RETRIEVED? NA. WILL ALL PIECES BE RETURNED WITH THE DEVICE? YES. IF NO, HOW WERE THEY DISCARDED? NA. THE ANALYSIS RESULTS CONFIRMED THAT THE JJ55H DEVICE WAS RETURNED NONFUNCTIONAL. THE INSTRUMENT WAS RECEIVED WITH THE HOOK LATCH DAMAGED AS THE HOOK LATCH WAS RECEIVED WITH THE PIN LOOSE. WHILE NO CONCLUSION COULD BE REACHED AS TO HOW THE DEVICE BECAME DAMAGED, IT SHOULD BE NOTED THAT AS PART OF OUR QUALITY PROCESS, EACH DEVICE IS VISUALLY INSPECTED AND FUNCTIONALLY TESTED DURING MANUFACTURING TO ENSURE THAT THE DEVICE MEETS THE REQUIRED SPECIFICATIONS PRIOR TO SHIPMENT. THE BATCH RECORD WAS REVIEWED AND NO ANOMALIES WERE NOTED DURING THE MANUFACTURING PROCESS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A GASTRECTOMY PROCEDURE, WHILE ATTACHING THE HANDLE, THE INTERMEDIATE LOCKING SCREW CAME OUT. IT IS UNKNOWN WHAT WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO ADVERSE CONSEQUENCES FOR THE PATIENT REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    680801 VALUTRUS LC HANDLE ODC ETHICON ENDO SURGERY, INC (CINCINNATI) NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1