BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROXIMATE PROXIMATE PLUS MD SKIN STAPLER

    MDR report key: 165392 · Received April 30, 1998

    Report

    Report Number
    1527736-1998-01308
    Event Type
    Malfunction
    Date Received
    April 30, 1998
    Date of Event
    March 26, 1998
    Report Date
    April 1, 1998
    Manufacturer
    ETHICON ENDO-SURGERY, INC.
    Product Code
    GDT
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    TRACKING #.51048 EES #.982367/J D5; H4: INFO NOT AVAILABLE. PROXIMATE PROXIMATE PROXIMATE PLUS MD SKIN STAPLER: BASED UPON INQUIRY REC'D, VISUAL EXAMINATION AND FUNCTIONAL TEST, ONE INSTRUMENT WAS REC'D IN GOOD CONDITION, IT WAS CYCLED AND FIRED 9 STAPLES WELL FORMED IN THE FOAM TEST AND 3 DRY FIRED, NO ANOMALIES COULD BE IDENTIFIED DURING TESTING. NO CONCLUSION COULD BE REACHED AS TO HOW THE REPORTED EVENT OCCURRED.

    Description of Event or Problem · 1

    IT WAS REPORTED BY THE REP THE DEVICE WAS USED DURING AN OPEN BOWEL PROCEDURE. IT WAS REPORTED THE SURGEON FELT THE STAPLES WERE NOT FORMING CORRECTLY BASED ON PREVIOUS EXPERIENCE. SURGEON OPENED ANOTHER PMW35 TO COMPLETE THE CASE. THERE WAS NO CONSEQUENCE TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PROXIMATE PROXIMATE PLUS MD SKIN STAPLER SKIN STAPLER GDT ETHICON ENDO-SURGERY, INC. NA K4896M

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Other