BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDOPATH REUSABLE ENDOSCOPIC NEEDLE HOLDER

    MDR report key: 162960 · Received April 15, 1998

    Report

    Report Number
    2210968-1998-00142
    Event Type
    Malfunction
    Date Received
    April 15, 1998
    Date of Event
    March 12, 1998
    Report Date
    March 19, 1998
    Manufacturer
    ETHICON, INC.
    Product Code
    FHQ
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    WILL NOT RELEASE: CUSTOMER REPORTS THAT NEEDLE HOLDERS WERE STICKING, WOULD NOT RELEASE. THERE ARE NO REPORTED ADVERSE CONSEQUENCES TO THE PT RELATED TO THIS EVENT. NOTE: OUTCOME TO PT DOES NOT DENOTE ADVERSE EVENT. MDR REGULATION OF 07/31/96 REQUIRES REPORTING OF INCIDENT ONCE MEDICAL DEVICE FAMILY INITIALLY REPORTED ASSUMING INCIDENT COULD RECUR. ETHICON INC'S INTERNAL CONTROL NUMBER IS: 9800252-00.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ENDOPATH REUSABLE ENDOSCOPIC NEEDLE HOLDER REUSABLE NEEDLE HOLDER FHQ ETHICON, INC. NA 42/95

    Patients

    Seq Age Sex Outcome Treatment
    1 NO INFO