BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RENEW ENDOCUT SCISSOR TIP, REUSABLE

    MDR report key: 6379199 · Received March 5, 2017

    Report

    Report Number
    1223422-2017-00023
    Event Type
    Malfunction
    Date Received
    March 5, 2017
    Date of Event
    January 21, 2017
    Report Date
    March 3, 2017
    Manufacturer
    MICROLINE SURGICAL, INC.
    Product Code
    GEI
    PMA / PMN Number
    K962119
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE LOT NUMBER OF THE RETURNED DEVICE IS UNKNOWN; THEREFORE, THE LOT HISTORY RECORD WAS NOT CHECK WAS NOT POSSIBLE. THE INVESTIGATION OF THE RETURNED PRODUCT IS NOT COMPLETED AT THE TIME OF THIS MDR SUBMISSION. THERE WAS NO HARM TO THE PATIENT.

    Description of Event or Problem · 1

    DURING A LAPAROSCOPIC CHOLECYSTECTOMY PROCEDURE, THE HEAT SHRINK FROM A RENEW ENDOCUT SCISSOR TIP DETACHED FROM THE DEVICE. THE SURGICAL PROCEDURE AND ANESTHESIA TIME WAS EXTENDED FOR FIVE (5) MINUTES. IN THIS SURGICAL PROCEDURE, TWO RENEW ENDOCUT SCISSOR TIPS WERE USED. THIS MDR 1223422-2017-00023 APPLIES TO ONE DEVICE REPORTING; AND THE SECOND DEVICE ISSUE IS DOCUMENTED AND REPORTED WITH MDR REFERENCE #1223422-2017-00022. THERE WAS NO HARM TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    161736 RENEW ENDOCUT SCISSOR TIP, REUSABLE MANUAL DETACHABLE SURGICAL INSTRUMENT GEI MICROLINE SURGICAL, INC. 3141 UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Other