BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VICRYL SUTURE, SH NEEDLE, 2-0

    MDR report key: 3051332 · Received April 10, 2013

    Report

    Report Number
    1527736-2013-00008
    Event Type
    Malfunction
    Date Received
    April 10, 2013
    Date of Event
    March 18, 2013
    Report Date
    March 18, 2013
    Manufacturer
    ETHICON ENDO SURGERY, INC (CINCINNATI)
    Product Code
    GCJ
    PMA / PMN Number
    K992612
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MS, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). INFORMATION ANTICIPATED, BUT UNAVAILABLE AT THIS TIME.

    Additional Manufacturer Narrative · 1

    (B)(4). THE ANALYSIS RESULTS FOUND THAT THE CARTRIDGE WAS RECEIVED WITH THE CARTRIDGE PLATE DISLODGED. SCRATCHES WERE FOUND IN DIFFERENT AREAS OF THE CARTRIDGE BODY INDICATING THAT EXCESSIVE FORCE WAS USED TO INTRODUCED THE ASD INSTRUMENT. THE POTENTIAL REASON OF THE LOADING OR UNLOADING FAILURE CAN BE CAUSED DUE TO INCORRECT INSTRUMENT USAGE. AS THE CARTRIDGE WAS NOT RECEIVED AND IT IS THE PART THAT HAS THE BATCH STAMPED, 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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A BARIATRIC ROUX-EN-Y PROCEDURE, A METAL CLIP BROKE OFF THE DEVICE AND FELL INTO THE PATIENT. THE METAL CLIP WAS RETRIEVED. THE CASE WAS COMPLETED WITH NO PATIENT CONSEQUENCES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    152900 VICRYL SUTURE, SH NEEDLE, 2-0 LAPAROSCOPE, GENERAL AND PLASTIC SURGERY GCJ ETHICON ENDO SURGERY, INC (CINCINNATI) NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1