BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RENEW FENESTRATED GRASPER TIP REUSABLE

    MDR report key: 6629187 · Received June 9, 2017

    Report

    Report Number
    1223422-2017-00074
    Event Type
    Injury
    Date Received
    June 9, 2017
    Date of Event
    March 3, 2017
    Report Date
    April 14, 2017
    Manufacturer
    MICROLINE SURGICAL, INC.
    Product Code
    GEI
    PMA / PMN Number
    K974066
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS RETURNED, DECONTAMINATED AND VISUALLY INVESTIGATED. UPON VISUAL INSPECTION THIS COMPLAINT HAS BEEN CONFIRMED. THE RETURNED TIP WAS RETURNED WITH A DEFECTIVE HEAT SHRINK. MICROLINE INC., HAS NOTICED AN INCREASE OF REPORTED DEVICES WITH THIS SIMILAR FAILURE. A CORRECTIVE ACTION PLAN HAS BEEN ISSUED IN EFFORTS TO ADDRESS THE INCREASE OF THESE TYPE OF FAILURES REF CAPA (B)(4).

    Description of Event or Problem · 1

    DURING A LAPAROSCOPIC SURGICAL PROCEDURE, THE HEAT SHRINK FROM THE RENEW FENESTRATED GRASPER TIP BROKE AND FELL INTO THE PATIENT. THE SURGEON WAS ABLE TO RETRIEVE THE PIECE. ANESTHESIA AND PROCEDURE TIME WAS EXTENDED FOR 2 MIN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    412307 RENEW FENESTRATED GRASPER TIP REUSABLE MANUAL DETACHABLE SURGICAL INSTRUMENTS GEI MICROLINE SURGICAL, INC. 3221 UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention