BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RENEW FENESTRATED GRASPER TIP, REUSABLE

    MDR report key: 6300730 · Received February 3, 2017

    Report

    Report Number
    1223422-2017-00003
    Event Type
    Malfunction
    Date Received
    February 3, 2017
    Date of Event
    October 31, 2016
    Report Date
    February 3, 2017
    Manufacturer
    MICROLINE SURGICAL, INC.
    Product Code
    GEI
    PMA / PMN Number
    K974066
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE RENEW FENESTRATED GRASPER TIP (#3221) WAS RETURNED AND INVESTIGATED AT MICROLINE SURGICAL, INC. THE FENESTRATED GRASPER TIP WAS MISALIGNED UPON INSPECTION. THE TIP WAS ATTACHED TO A FUNCTIONAL RENEW HANDPIECE FOR FUNCTIONALITY TESTING. THE TIP WAS NOT FUNCTIONAL. THERE WAS NO HARM TO THE PATIENT. LATE MDR NARRATIVE: MICROLINE SURGICAL, INC., IS SUBMITTING THIS LATE MDR 1223422-2017-00003 (PAST 30-DAYS) DUE TO THE STAFF RESPONSIBLE FOR THE INVESTIGATION LEAVING, AND LACK OF STAFF TO COMPLETE THE TASK, INCLUDING LACK OF FULL INFORMATION AVAILABLE ON THE COMPLAINT TO SUBMIT THE MDR. MICROLINE SURGICAL, INC., WILL CONTINUE TO ENSURE ITS DUE DILIGENCE IN POST-MARKET COMPLAINTS HANDLING, AND ENSURING THAT ALL REQUIREMENTS FOR THE MEDICAL DEVICE EMDR REPORTING HAVE BEEN MET.

    Description of Event or Problem · 1

    DURING A COLON RESECTION SURGICAL PROCEDURE, THE RENEW FENESTRATED GRASPER TIP (#3221) BENDED AND BECAME MISALIGNED. THE SURGICAL PROCEDURE AND ANESTHESIA TIME WAS EXTENDED BY 20 MINUTES. THERE WAS NO HARM TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    83653 RENEW FENESTRATED GRASPER TIP, REUSABLE MANUAL DETACHABLE SURGICAL INSTRUMENT GEI MICROLINE SURGICAL, INC. 3221 00128481

    Patients

    Seq Age Sex Outcome Treatment
    1 Other