BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GEM MICROVASCULAR ANASTOMOTIC COUPLER

    MDR report key: 6210722 · Received December 28, 2016

    Report

    Report Number
    1416980-2016-18816
    Event Type
    Malfunction
    Date Received
    December 28, 2016
    Date of Event
    November 28, 2016
    Report Date
    December 28, 2016
    Manufacturer
    SYNOVIS SURGICAL INNOVATIONS
    Product Code
    MVR
    PMA / PMN Number
    K861985
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(6). THE DEVICE HISTORY RECORD WAS OBTAINED AND REVIEWED FOR LOT SP16H12-1173474. THE LOT PASSED VISUAL AND FUNCTIONAL INSPECTION. THE COUPLER RING SEPARATION FORCE RESULTS NOTED IN THE DHR FOR THIS LOT WERE WITHIN SPECIFICATION. THE COUPLER RING RETENTION FORCE TEST RESULTS WERE WITHIN SPECIFICATION. A 100% FUNCTIONAL ALIGNMENT TESTING WAS PERFORMED ON EACH DEVICE DURING THE MANUFACTURING PROCESS. IN ADDITION, 100% VISUAL INSPECTION FOR BROKEN OR MISSING PARTS WAS PERFORMED. THE RELEASED PRODUCT MET SPECIFICATION. PRODUCT WAS NOT RETURNED. PHYSICAL DESCRIPTION COULD NOT BE OBTAINED. FUNCTIONAL TESTING COULD NOT BE PERFORMED. THE ROOT CAUSE OF THE EVENT COULD NOT BE DETERMINED. THE DHR REVIEW INDICATES THAT THE LOT MET SPECIFICATION. THERE IS NO IMMEDIATE EVIDENCE TO SUPPORT WHY THE RINGS BECAME MISALIGNED DURING USE. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A 2.0MM GEM MICROVASCULAR ANASTOMOTIC COUPLER WAS SELECTED FOR A VENOUS ANASTOMOSIS. THE COUPLER RINGS DID NOT ALIGN UP WHEN CLOSED, SO THE PINS DID NOT MATCH UP AND LOCK IN TO THE OPPOSING RING. THE ANASTOMOSIS HAD TO BE REDONE WITH A DIFFERENT COUPLER IMPLANT. ANOTHER 2.0MM COUPLER FROM THE SAME LOT WAS USED WITH NO ISSUES. NO ADVERSE PATIENT IMPACT WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    860387 GEM MICROVASCULAR ANASTOMOTIC COUPLER GEM COUPLER MVR SYNOVIS SURGICAL INNOVATIONS GEM2752 SP16H12-1173474

    Patients

    Seq Age Sex Outcome Treatment
    1