BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROXIMATE I L S INTRALUMINAL STAPLER

    MDR report key: 164082 · Received April 21, 1998

    Report

    Report Number
    1527736-1998-01237
    Event Type
    Malfunction
    Date Received
    April 21, 1998
    Date of Event
    March 19, 1998
    Report Date
    March 27, 1998
    Manufacturer
    ETHICON ENDO-SURGERY
    Product Code
    GAG
    Removal / Correction Number
    NA
    Report Source
    Manufacturer report
    Reporter Location
    SW
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    TRACKING #.50895. EES #.982225/A. D6: INFO NOT AVAILABLE, DEVICE NOT RETURNED FOR ANALYSIS. PROXIMATE* I L S INTRALUMINAL STAPLER: WHILE CO WAS UNABLE TO ANALYZE THE INSTRUMENT UTILIZED IN THE REPORTED EVENT AS THE INSTRUMENT WAS NOT RETURNED TO CO, CO HAS DOCUMENTED THE CIRCUMSTANCES AS THEY WERE REPORTED TO US.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE CDH29 WAS USED DURING A LOW ANTERIOR RESECTION. IT WAS REPORTED BY THE AFFILIATE THAT WHEN THE NURSE UNPACKED THE INSTRUMENT, THE DEVICE HAD ALREADY BEEN FIRED. SOME STAPLES WERE STILL THERE BUT MOST WERE GONE. A NEW CDH29 WAS USED TO COMPLETE THE CASE. THERE WAS NO CONSEQUENCE TO THE PT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PROXIMATE I L S INTRALUMINAL STAPLER CIRCULAR STAPLER GAG ETHICON ENDO-SURGERY NA K4611X

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Other