BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RENEW FENESTRATED GRASPER TIP REUSABLE

    MDR report key: 6629215 · Received June 9, 2017

    Report

    Report Number
    1223422-2017-00083
    Event Type
    Injury
    Date Received
    June 9, 2017
    Date of Event
    May 5, 2017
    Report Date
    May 9, 2017
    Manufacturer
    MICROLINE SURGICAL, INC.
    Product Code
    GEI
    PMA / PMN Number
    K974066
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, 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 FAILURES. REF (B)(4).

    Description of Event or Problem · 1

    DURING A SURGICAL PROCEDURE, THE HEAT SHRINK FORM THE RENEW FENESTRATED GRASPER TIP FELL INTO A PATIENT. THE PROCEDURE AND ANESTHESIA TIME WAS NOT EXTENDED. THERE WAS HARM TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    412865 RENEW FENESTRATED GRASPER TIP REUSABLE MANUAL DETACHABLE SURGICAL INSTRUMENTS GEI MICROLINE SURGICAL, INC. 3221 UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention