BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROXIMATE RELOADABLE LINEAR STAPLER

    MDR report key: 178370 · Received July 21, 1998

    Report

    Report Number
    1527736-1998-02096
    Event Type
    Malfunction
    Date Received
    July 21, 1998
    Report Date
    July 7, 1998
    Manufacturer
    ETHICON ENDO-SURGERY - ALB
    Product Code
    GAG
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    UNKNOWN

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A XR30B WAS USED DURING AN UNK PROCEDURE. IT WAS REPORTED BY THE AFFILIATE THAT THE JAW WOULD NOT OPEN, SINCE THE PIN DID NOT MOVE (COULD FINALLY OPEN). THERE WAS NO CONSEQUENCE TO THE PT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PROXIMATE RELOADABLE LINEAR STAPLER LINEAR STAPLERS GAG ETHICON ENDO-SURGERY - ALB NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Other