BEUDAMED
    FDA Adverse Event Other Summary report: N

    VC EVH, OD, SMR, VD, BP

    MDR report key: 2371679 · Received December 8, 2011

    Report

    Report Number
    1718850-2011-00238
    Event Type
    Other
    Date Received
    December 8, 2011
    Date of Event
    October 29, 2011
    Report Date
    November 9, 2011
    Manufacturer
    SORIN GROUP USA, INC.
    Product Code
    GEI
    PMA / PMN Number
    K102983
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    SORIN GROUP USA RECEIVED A COMPLAINT REPORTING THAT, TOWARDS THE END OF A PROCEDURE, THE JAW OF THE BIPOLAR BROKE OFF. THE PIECE WAS REPORTEDLY RETRIEVED AND DISCARDED. THE USER REPORTED THAT HE BELIEVED HE APPLIED TORQUE TO THE BIPOLAR AND THE JAW BROKE OFF. THERE WAS NO PATIENT INJURY. THE BIPOLAR WAS RETURNED TO SORIN GROUP USA FOR EVALUATION. THE INVESTIGATION IS ONGOING. A FOLLOW-UP REPORT WILL BE FILED WHEN THE INVESTIGATION IS COMPLETE.

    Description of Event or Problem · 1

    SORIN GROUP RECEIVED A COMPLAINT REPORTING THAT, TOWARDS THE END OF A PROCEDURE, THE JAW OF THE BIPOLAR BROKE OFF. THE PIECE WAS REPORTEDLY RETRIEVED AND DISCARDED. THE USER REPORTED THAT HE BELIEVED HE APPLIED TORQUE TO THE BIPOLAR AND THE JAW BROKE OFF. THERE WAS NO PATIENT INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VC EVH, OD, SMR, VD, BP BIPOLAR DEVICE GEI SORIN GROUP USA, INC. NA 1114300074

    Patients

    Seq Age Sex Outcome Treatment
    1