BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RENEW TRADITIONAL MARYLAND DISSECTOR FORCEPS TIPS

    MDR report key: 6629179 · Received June 9, 2017

    Report

    Report Number
    1223422-2017-00072
    Event Type
    Injury
    Date Received
    June 9, 2017
    Date of Event
    April 5, 2017
    Report Date
    April 5, 2017
    Manufacturer
    MICROLINE SURGICAL, INC.
    Product Code
    GEI
    PMA / PMN Number
    K981389
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE ACTUAL DEVICE WAS NOT RETURNED TO MICROLINE SURGICAL. THE BROKE PIECE OF THE HEAT SHRINK WAS RETURNED. UPON VISUAL EXAMINATION, ITS CLEAR THAT THIS COMPLAINT IS CONFIRMED. THE RETURNED PIECE APPEARS TO BE PART OF THE SEPARATED HEAT SHRINK. THIS IS A KNOWN ISSUE AND WILL BE ADDRESSED BY CAPA (B)(4). 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.

    Description of Event or Problem · 1

    DURING A LAPAROSCOPIC CHOLECYSTECTOMY PROCEDURE, THE HEAT SHRINK FROM THE RENEW TRADITIONAL MARYLAND GRASPER TIP FELL INTO THE ABDOMEN OF THE PATIENT. THE PROCEDURE AND ANESTHESIA TIME WAS NOT EXTENDED. THERE WAS NO HARM TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    412136 RENEW TRADITIONAL MARYLAND DISSECTOR FORCEPS TIPS MANUAL DETACHABLE SURGICAL INSTRUMENTS GEI MICROLINE SURGICAL, INC. 3352 00128709

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention