BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PWRD 23MM CURVED CIRCULAR, 18CM SHAFT

    MDR report key: 10548754 · Received September 17, 2020

    Report

    Report Number
    3005075853-2020-04721
    Event Type
    Malfunction
    Date Received
    September 17, 2020
    Date of Event
    August 21, 2020
    Report Date
    August 24, 2020
    Manufacturer
    ETHICON ENDO-SURGERY, LLC.
    Product Code
    GDW
    UDI-DI
    10705036015369
    PMA / PMN Number
    K163523
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). DATE SENT: 02/25/2021. PLEASE SEE H11. H11: CORRECTED DATA = H6: COMPONENT CODE = ELECTRICAL AND MAGNETIC (G02).

    Additional Manufacturer Narrative · 0

    (B)(4). DATE SENT: 10/09/20230. DEVICE ANALYSIS: THE ANALYSIS RESULTS FOUND THAT THE CDH29P DEVICE ARRIVED WITH NO APPARENT DAMAGED. THE DEVICE STILL HAD STAPLES, CONFIRMING THAT IT WAS NOT FIRED. UPON INSTALLATION OF THE BATTERY, THE GREEN CHECK WAS ILLUMINATED, INDICATING THE DEVICE WAS NOT RESET BEFORE STAPLES WERE LOADED DURING MANUFACTURING PROCESS. THE DEVICE WAS RESET USING A REVERSE BATTERY AND TESTED FOR FUNCTIONALITY. THE DEVICE FUNCTIONED AS INTENDED AND FORMED ALL THE STAPLES AS WELL AS COMPLETELY CUT THE TEST MEDIA AND THE BREAKAWAY WASHER WITHOUT INCIDENT. THE STAPLE LINE WAS COMPLETE AND MET THE RELEASE CRITERIA. DURING ANALYSIS, THE ADJUSTING KNOB MOVEMENT WAS FOUND TO BE ABNORMAL. IT WAS OBSERVED THAT THE INDICATOR LENS WAS NOT COMPLETELY SEATED DUE TO MISALIGNMENT OF THE SHROUDS. THE LENS COULD BE SEATED CORRECTLY BY PRESSING DOWN ON THE LENS. THIS CONDITION OF THE LENS HOWEVER DID NOT IMPACT THE PRODUCT OF EXPERIENCE OF WOULD NOT FIRE. PER THE CONDITION OF THE SAMPLE RECEIVED APPEARS THAT DEVICE WAS FIRED DURING MANUFACTURING PROCESS BUT NOT RESET BEFORE RELOADING THE STAPLES. NO CONCLUSION COULD BE REACHED AS WHAT MAY HAVE CAUSED THE FAILURE OF THE MISALIGNMENT OF THE SHROUDS. IT SHOULD BE NOTED THAT AS PART OF OUR QUALITY PROCESS ALL DEVICES ARE MANUFACTURED, INSPECTED, AND RELEASED TO APPROVED SPECIFICATIONS.

    Additional Manufacturer Narrative · 1

    (B)(4). BATCH #: T5D012. ATTEMPTS HAVE BEEN MADE TO RETRIEVE THE DEVICE. TO DATE, THE DEVICE HAS NOT BEEN RETURNED. IF THE DEVICE OR FURTHER DETAILS ARE RECEIVED AT A LATER DATE, A SUPPLEMENTAL MEDWATCH WILL BE SENT. A MANUFACTURING RECORD EVALUATION WAS PERFORMED FOR THE FINISHED DEVICE AND THE MANUFACTURING CRITERIA WERE MET PRIOR TO THE RELEASE OF THIS LOT/BATCH. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL REPORT, A FOLLOW-UP REPORT WILL BE FILED AS APPROPRIATE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING AN ONCOLOGICAL SURGERY, THE STAPLER WOULD NOT WORK. THE SURGEON SAID THE NURSE GAVE HIM THE STAPLER WITH GREEN CHECK MARK ON, AND HE WAS ABLE TO REGULATE THE STAPLER HEIGHT ON THE SCREEN AND CLOSED THE STAPLER ON THE SCALE. HE PRESSED THE FIRING BUTTON AND NOTHING HAPPENED. THEY REMOVED THE STAPLER AND REPLACED IT WITH THE NEW ONE THAT WORKED PROPERLY. THERE WERE NO PATIENT CONSEQUENCES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1015445 PWRD 23MM CURVED CIRCULAR, 18CM SHAFT STAPLE, IMPLANTABLE GDW ETHICON ENDO-SURGERY, LLC. CDH23P T93R80 10705036015369

    Patients

    Seq Age Sex Outcome Treatment
    1