BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GEM MICROVASCULAR ANASTOMOTIC COUPLER

    MDR report key: 6018379 · Received October 11, 2016

    Report

    Report Number
    1416980-2016-16154
    Event Type
    Malfunction
    Date Received
    October 11, 2016
    Date of Event
    September 13, 2016
    Report Date
    November 9, 2016
    Manufacturer
    SYNOVIS SURGICAL INNOVATIONS
    Product Code
    MVR
    PMA / PMN Number
    K861985
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 1

    DEVICE HISTORY RECORD REVIEW WAS COMPLETED. NO IRREGULARITIES WERE FOUND WHEN REVIEWING SUPPLIER RECORDS. THE COUPLER RING SEPARATION TESTING WAS COMPETED AT THE SUPPLIER WITH PASSING RESULTS. THE 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. RING RETENTION TESTING WAS COMPLETED AT INCOMING INSPECTION WITH PASSING RESULTS. THE RELEASED PRODUCT MET SPECIFICATION. ONE 2.5MM GEM COUPLER DEVICE WAS RETURNED FOR EVALUATION. BOTH OF THE COUPLER RINGS, THE WING JAW ASSEMBLY, AND THE PROTECTIVE SHEATH WERE EVALUATED. THE RINGS WERE EXAMINED UNDER MAGNIFICATION. IT IS UNKNOWN IF THE USER FULLY SQUEEZED THE RINGS TOGETHER. THE SURFACE OF THE RINGS DO NOT HAVE EXTRANEOUS MARKS INDICATING THAT THE RINGS CAME TOGETHER MISALIGNED. THERE IS ONE DISTORTED PIN THAT WOULD PREVENT THE RINGS FROM COMING TOGETHER PROPERLY. OTHER DETAILS OF THE EVENT COULD NOT BE VERIFIED AND THE RING APPEARS TO MEET SPECIFICATIONS. NO FUNCTIONAL TESTING WAS PERFORMED ON THE COUPLER RINGS. ONCE THE RINGS HAVE BEEN INSERTED INTO THE JAW ASSEMBLY AND REMOVED, THE RING RETENTION FORCE INSIDE THE JAW ASSEMBLY IS REDUCED WHEN INSERTED AND REMOVED A SECOND TIME. IN ADDITION, WITH THE BENT PIN ON THE ONE RING, THE SEPARATION FORCE COULD NOT BE PERFORMED BECAUSE THE RINGS WILL NOT ALIGN PROPERLY. THE WING JAW ASSEMBLY CONTAINING NO RINGS WAS PLACED ONTO A TEST ANASTOMOTIC INSTRUMENT. THE INSTRUMENT WAS CYCLED AND THE LEFT AND RIGHT WINGS APPROXIMATED CORRECTLY. THE FAILURE MODE AS REPORTED "COUPLER WOULD NOT CLOSE" COULD NOT BE VERIFIED. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A GEM2753 COUPLER DID NOT CLOSE DURING SURGERY. THIS WAS AN ENT PROCEDURE ON A MALE (B)(6). THE SURGEON USED ANOTHER COUPLER TO FINISH THE PROCEDURE. THE PATIENT IS DOING WELL. NO ADVERSE OUTCOME WAS REPORTED. IT IS NOT KNOWN WHEN THE PRODUCT DEFECT WAS OBSERVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    667849 GEM MICROVASCULAR ANASTOMOTIC COUPLER ANASTOMOTIC COUPLER MVR SYNOVIS SURGICAL INNOVATIONS GEM2753 SNSP15F18-1056780

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR