BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ROTATING MULTIPLE CLIP APPLIER

    MDR report key: 3920010 · Received July 8, 2014

    Report

    Report Number
    3005075853-2014-04761
    Event Type
    Malfunction
    Date Received
    July 8, 2014
    Date of Event
    June 16, 2014
    Report Date
    June 26, 2014
    Manufacturer
    ETHICON ENDO-SURGERY, LLC.
    Product Code
    FZP
    PMA / PMN Number
    K864102
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). ADDITIONAL INFORMATION: THE ANALYSIS RESULTS FOR THE ER320 DEVICE FOUND THAT IT WAS RETURNED WITH THE SHAFT BENT. NO FUNCTIONAL TESTING COULD BE PERFORMED DUE TO THE RETURNED CONDITION OF THE DEVICE. POSSIBLE CAUSES FOR THE DAMAGE FOUND MAY BE INADVERTENT PRESSURE PLACED ON THE DEVICE SHAFT THROUGH BENDING, PRESSING AGAINST THE TROCAR, OTHER DEVICES ON THE BACK TABLE, USING THE DEVICE AS A RETRACTOR OR MOVING HEAVY TISSUE WITH THE DEVICE SHAFT. HOWEVER, IT COULD NOT BE DETERMINED WHAT TO MAY HAVE CAUSED THE REPORTED INCIDENT. THE BATCH RECORD WAS REVIEWED AND NO ANOMALIES WERE NOTED DURING THE MANUFACTURING PROCESS.

    Additional Manufacturer Narrative · 1

    (B)(4). UPON REVIEW OF THE INFORMATION PROVIDED, IT WAS CONCLUDED THAT THIS EVENT DOES NOT MEET THE FDA DEFINED CRITERIA FOR A REPORTABLE EVENT, AND IS BEING CONSIDERED NOT REPORTABLE.

    Additional Manufacturer Narrative · 1

    (B)(4). ADDITIONAL INFORMATION WAS REQUESTED AND THE FOLLOWING WAS OBTAINED: HOW WAS THE PROCEDURE COMPLETED? THE BENT PART WAS NOTICED PRIOR TO ANY PROCEDURE BEING STARTED. HOW WAS THE PROCEDURE COMPLETED? NEVER STARTED WITH THIS PRODUCT WAS THERE ANY PATIENT CONSEQUENCE? NO.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE, THE TIP WAS BENT ON THE DEVICE. IT IS UNKNOWN HOW THE CASE WAS COMPLETED. THERE WERE NO PATIENT CONSEQUENCES REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    396485 ROTATING MULTIPLE CLIP APPLIER CLIP, IMPLANTABLE FZP ETHICON ENDO-SURGERY, LLC. NA L4E747

    Patients

    Seq Age Sex Outcome Treatment
    1