BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FEA,JAW,GRSPR,D/A,ARTMTC - INTERCEPTRE

    MDR report key: 383307 · Received March 12, 2002

    Report

    Report Number
    1219602-2002-00045
    Event Type
    Malfunction
    Date Received
    March 12, 2002
    Report Date
    March 12, 2002
    Manufacturer
    SMITH & NEPHEW, INC.ENDOSCOPY DIVIS
    Product Code
    KOG
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    THE GRASPER JAW BROKE DURING USE. THERE WAS A 10-MINUTE SURGICAL DELAY. THERE WAS NO PATIENT INJURY OR FURTHER PROCEDURAL COMPLICATIONS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 FEA,JAW,GRSPR,D/A,ARTMTC - INTERCEPTRE GRASPER HAND HELD INSTRUMENT KOG SMITH & NEPHEW, INC.ENDOSCOPY DIVIS NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN