BEUDAMED
    FDA Adverse Event Other Summary report: N

    RESCULP SURGICAL INSTRUMENTS

    MDR report key: 5910108 · Received August 25, 2016

    Report

    Report Number
    MW5064377
    Event Type
    Other
    Date Received
    August 25, 2016
    Date of Event
    August 11, 2016
    Report Date
    August 17, 2016
    Manufacturer
    AESCULAP INC.
    Product Code
    HTD
    Report Source
    Voluntary report
    Reporter Location
    NJ, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    DURING LAP CHOLECYSTECTOMY GRASPING TISSUE USING RESCULPT GRASPER, PIECE OF END OF GRASPER BROKE OFF INTO PT. CAVITY. MINUTE PIECE OF METAL RETRIEVED. XRAY OF ABD. INCONCLUSIVE FOR FOREIGN BODY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    554693 RESCULP SURGICAL INSTRUMENTS UNIVERSAL GRASPING FORCEPS - 5MM HTD AESCULAP INC. PO128R 31CM

    Patients

    Seq Age Sex Outcome Treatment
    1 52 YR Other