BEUDAMED
    FDA Adverse Event Other Summary report: N

    RENEW IV NON-RATCHETED HANDPIECE, 34CM

    MDR report key: 1914364 · Received November 17, 2010

    Report

    Report Number
    1223422-2010-00005
    Event Type
    Other
    Date Received
    November 17, 2010
    Report Date
    November 17, 2010
    Manufacturer
    MICROLINE SURGICAL INC
    Product Code
    GEI
    PMA / PMN Number
    K962119
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL MODEL #, LOT#, SERIAL #, MFG DATE: (B)(4) RENEW VI NON-RATCHETED HANDPIECE, 34CM, LOT# 44654, (B)(4), MFG DATE 05/07/2008; (B)(4) RENEW VI NON-RATCHETED HANDPIECE, 34CM, LOT# 46928, (B)(4), MFG DATE 12/08/2008; (B)(4) RENEW VI NON-RATCHETED HANDPIECE, 34CM, LOT# 42505, (B)(4), MFG DATE 01/09/2008. THE HOSPITAL IS RETURNING FOUR HANDPIECES, THEY ARE NOT SURE WHICH ONE WAS INVOLVED IN THE INCIDENT. NO ADD'L PT INFO WAS PROVIDED. THE FOUR PRODUCTS IN QUESTION WERE NOT RETURNED, THEREFORE, NO INVESTIGATION COULD BE CONDUCTED. NO ISSUES WERE FOUND WITH ANY OF THE DEVICE HISTORY RECORDS.

    Description of Event or Problem · 1

    MICROLINE SURGICAL WAS INFORMED BY THE DISTRIBUTOR THAT A RENEW HANDPIECE MAY HAVE CAUSED A BURN TO A PT'S UTERUS. THE HOSP IS RETURNING FOUR RENEW HANDPIECES BECAUSE THEY ARE NOT SURE WHICH ONE MAY HAVE BEEN INVOLVED IN THE INCIDENT. NO PT INFO WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RENEW IV NON-RATCHETED HANDPIECE, 34CM HANDPIECE GEI MICROLINE SURGICAL INC 3904 46161

    Patients

    Seq Age Sex Outcome Treatment
    1