BEUDAMED
    FDA Adverse Event Other Summary report: N

    RENEW ENDOCUT SCISSOR TIP, DISPOSABLE

    MDR report key: 4188452 · Received October 17, 2014

    Report

    Report Number
    1223422-2014-00036
    Event Type
    Other
    Date Received
    October 17, 2014
    Report Date
    October 14, 2014
    Manufacturer
    MICROLINE SURGICAL INC
    Product Code
    GEI
    PMA / PMN Number
    K962119
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION FINDINGS: THE SCISSOR TIP WAS RETURNED AND INVESTIGATED. CUSTOMER'S STATED COMPLAINT THAT DURING A SURGICAL PT. THE SCISSOR TIP WAS VISUALLY INSPECTED AND MECHANICALLY TESTED AND THE SCISSOR TIP FUNCTIONED AS HANDPIECE THAT WAS RETURNED WITH THE SCISSOR TIP WAS INSPECTED. THE VISUAL AND MECHANICAL TESTING DID NOT REVEALED ANY NON-CONFORMING PERFORMANCE WITH THE DEVICE. THE SCISSOR TIP AND THE HANDPIECE WERE CONNECTED ACCORDING TO THE INSTRUCTIONS IN THE IFU. THE RESULT IS A TIGHT BOND BETWEEN THE TWO DEVICES. THE CONNECTION WAS TESTED WITH A PUSH AND PULL TEST. THESE TESTS WERE UNSUCCESSFUL FOR SEPARATING THE TWO DEVICES AND THE CUSTOMER'S STATED COMPLAINT COULD NOT BE DUPLICATED. HOWEVER, FAILURE TO FOLLOW THE IFU INSTRUCTIONS, MAY HAVE RESULTED IN AN INCORRECTLY INSTALLED SCISSOR TIP WHICH WAS NOT COMPLETELY TIGHTENED ONTO THE HANDPIECE AND MAY HAVE BECOME LOOSE.

    Description of Event or Problem · 1

    DURING A SURGICAL PROCEDURE, THE SCISSOR TIP FELL OFF THE HANDLE AND INTO THE PT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    661429 RENEW ENDOCUT SCISSOR TIP, DISPOSABLE MANUAL DETACHABLE SURGICAL INSTRUMENTS GEI MICROLINE SURGICAL INC 3142 00117864

    Patients

    Seq Age Sex Outcome Treatment
    1 Other