BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RENEW FENESTRATED GRASPER TIP, REUSABLE (MODEL #3221)

    MDR report key: 6415650 · Received March 17, 2017

    Report

    Report Number
    1223422-2017-00030
    Event Type
    Malfunction
    Date Received
    March 17, 2017
    Date of Event
    January 14, 2017
    Report Date
    March 17, 2017
    Manufacturer
    MICROLINE SURGICAL, INC.
    Product Code
    GEI
    PMA / PMN Number
    K981389
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS NOT RETURNED TO THE MANUFACTURER. THERE WAS NO EVALUATION WAS CONDUCTED. THERE WAS NO HARM TO THE PATIENT. FDA REFERENCE REPORT: MW5067476 [SENT BY U.S. FDA TO MICROLINE SURGICAL, INC., AND RECEIVED ON 02/14/2017]. DEVICE NOT RETURNED TO MANUFACTURER.

    Description of Event or Problem · 1

    DURING A LAPAROSCOPIC CHOLECYSTECTOMY, SURGICAL PROCEDURE, THE HEAT SHRINK FROM THE RENEW FENESTRATED GRASPER TIP BROKE AND FELL INTO THE PATIENT. THE BROKEN PIECE WAS IDENTIFIED AND RETRIEVED FROM THE PATIENT. THERE WAS NO HARM TO THE PATIENT. FDA REFERENCE REPORT: MW5067476 [SENT BY U.S. FDA TO MICROLINE SURGICAL, INC., AND RECEIVED ON 02/14/2017].

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    195664 RENEW FENESTRATED GRASPER TIP, REUSABLE (MODEL #3221) MANULA DETACHABLE SURGICAL INSTRUMENTS GEI MICROLINE SURGICAL, INC. 3221 UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Other