BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    REFLEX TL, SKIN STAPLER WITH TISSUE LIFT, 35 WIDE

    MDR report key: 17850273 · Received October 2, 2023

    Report

    Report Number
    3007305485-2023-00210
    Event Type
    Malfunction
    Date Received
    October 2, 2023
    Report Date
    October 23, 2023
    Manufacturer
    CONSOLIDATED MEDICAL EQUIPMENT COMPANY
    Product Code
    FZQ
    UDI-DI
    10653405050605
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    RECEIVED ONE 3013 IN UNORIGINAL PACKAGING. LOT NUMBER WAS NOT VERIFIED. PERFORMED A VISUAL INSPECTION, THE DEVICE WAS RETURNED WITH ZERO CLIPS REMAINING. THERE APPEARED TO BE A LOOSE OBJECT WITHIN THE DEVICE. PERFORMED A FUNCTIONAL INSPECTION, WHEN PULLING THE TRIGGER, THE DEVICE CATCHES AND THE METAL PIECES AT THE DISTAL END ARE RUBBING AGAINST ONE ANOTHER. THE MANUFACTURING DOCUMENTS FROM THE DEVICE HISTORY RECORD HAVE BEEN REVIEWED WITH SPECIAL ATTENTION TO THE MANUFACTURING AND INSPECTION OF THE PRODUCT. THE PRODUCT RELEASED FOR DISTRIBUTION WAS FOUND TO HAVE MET ALL SPECIFICATIONS PRIOR TO SHIPMENT. THIS IS THE ONLY COMPLAINT FOR THIS LOT NUMBER AND FAILURE MODE WITHIN THE PAST TWO YEARS. (B)(4). PER THE INSTRUCTIONS FOR USE, THE USER IS ADVISED TO ALWAYS ENSURE TRIGGER IS FULLY CLOSED AND RELEASED TO PROPERLY FEED THE NEXT STAPLE INTO POSITION. WE WILL CONTINUE TO MONITOR FOR TRENDS THROUGH THE COMPLAINT SYSTEM TO ASSURE PATIENT SAFETY.

    Additional Manufacturer Narrative · 0

    THE REPORTED DEVICE HAS BEEN RETURNED TO CONMED; HOWEVER, THE EVALUATION OF THE DEVICE HAS NOT BEEN COMPLETED. A SUPPLEMENTAL AND FINAL REPORT WILL BE FILED FOLLOWING THE COMPLETION OF THE DEVICE EVALUATION AND COMPLAINT INVESTIGATION. WE WILL CONTINUE TO MONITOR FOR TRENDS THROUGH THE COMPLAINT SYSTEM TO ASSURE PATIENT SAFETY.

    Description of Event or Problem · 0

    THE DISTRIBUTOR REPORTED ON BEHALF OF THEIR CUSTOMER THAT THE 3013, REFLEX TL, SKIN STAPLER WITH TISSUE LIFT, 35 WIDE, WAS INITIALLY BEING RETURNED DUE TO A SHIPPING ERROR. HOWEVER, UPON THE WAREHOUSE¿S RECEIPT OF THE RETURNING DEVICE AN INVOICE IN THE BOX FOUND THAT THE REASON FOR RETURN WAS NOT AS PREVIOUSLY REPORTED. THE INVOICE STATED, ¿THAT THE REFLEX STAPLER DID NOT RELEASE TISSUE WHEN STAPLER IS RELEASED RESULTING IN IMPROPER PLACEMENT OF STAPLES ALONG INCISION AND JAMMING OF STAPLER.¿ THERE WAS NO REPORT OF INJURY, MEDICAL INTERVENTION, OR HOSPITALIZATION FOR THE PATIENT OR USER. THIS REPORT IS BEING RAISED DUE TO THE REPORTED MALFUNCTION WITH POTENTIAL FOR INJURY UPON REOCCURRENCE.

    Description of Event or Problem · 0

    THE DISTRIBUTOR REPORTED ON BEHALF OF THEIR CUSTOMER THAT THE 3013, REFLEX TL, SKIN STAPLER WITH TISSUE LIFT, 35 WIDE, WAS INITIALLY BEING RETURNED DUE TO A SHIPPING ERROR. HOWEVER, UPON THE WAREHOUSE¿S RECEIPT OF THE RETURNING DEVICE AN INVOICE IN THE BOX FOUND THAT THE REASON FOR RETURN WAS NOT AS PREVIOUSLY REPORTED. THE INVOICE STATED, ¿THAT THE REFLEX STAPLER DID NOT RELEASE TISSUE WHEN STAPLER IS RELEASED RESULTING IN IMPROPER PLACEMENT OF STAPLES ALONG INCISION AND JAMMING OF STAPLER.¿ THERE WAS NO REPORT OF INJURY, MEDICAL INTERVENTION, OR HOSPITALIZATION FOR THE PATIENT OR USER. THIS REPORT IS BEING RAISED DUE TO THE REPORTED MALFUNCTION WITH POTENTIAL FOR INJURY UPON REOCCURRENCE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1003636 REFLEX TL, SKIN STAPLER WITH TISSUE LIFT, 35 WIDE CLIP, REMOVABLE (SKIN) FZQ CONSOLIDATED MEDICAL EQUIPMENT COMPANY 202209145 10653405050605

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown