BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GEM MICROVASCULAR ANASTOMOTIC COUPLER

    MDR report key: 22866844 · Received August 21, 2025

    Report

    Report Number
    1416980-2025-04295
    Event Type
    Malfunction
    Date Received
    August 21, 2025
    Date of Event
    July 9, 2025
    Report Date
    September 22, 2025
    Manufacturer
    BAXTER HEALTHCARE CORPORATION
    Product Code
    MVR
    UDI-DI
    0844735002669
    PMA / PMN Number
    K861985
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    D4 LOT #: THE SUSPECT LOT WAS EITHER SP24E08-2068261 OR SP24E21-2075540 OR SP24K12-2173419. D4 INFORMATION - FOR SUSPECT LOT SP24E08-2068261 UDI IS (B)(4), SP24E08-2068261. FOR SUSPECT LOT SP24E21-2075540 UDI IS (B)(4), SP24E21-2075540. FOR SUSPECT LOT SP24K12-2173419 UDI IS (B)(4), SP24K12-2173419. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 0

    CORRECTION TO F10/H6: MEDICAL DEVICE PROBLEM CODES. ADDITIONAL INFORMATION: D4(EXPIRATION DATE AND UDI#), D9, H3, H4, H6 (UPDATE CODES), H11. FOR SUSPECT LOT SP24E08-2068261, D4: EXPIRATION DATE: 04/01/2029 AND UDI# IS (B)(4). FOR SUSPECT LOT SP24E21-2075540, D4: EXPIRATION DATE: 04/25/2029 AND UDI# IS (B)(4). FOR SUSPECT LOT SP24K12-2173419, D4: EXPIRATION DATE: 10/10/2029 AND UDI# IS (B)(4). FOR SUSPECT LOT SP24E08-2068261, H4: DEVICE MANUFACTURE DATE: 04/01/2024. FOR SUSPECT LOT SP24E21-2075540, H4: DEVICE MANUFACTURE DATE: 04/25/2024. FOR SUSPECT LOT SP24K12-2173419, H4: DEVICE MANUFACTURE DATE: 10/10/2024. H11: THE DEVICE WAS RECEIVED FOR EVALUATION. THE 2.5MM COUPLER JAW ASSEMBLY DID NOT IDENTIFY ANY ABNORMALITIES THAT COULD HAVE CONTRIBUTED TO THE REPORTED CONDITION. DURING VISUAL INSPECTION, SIGNS OF USE (DRIED BLOOD AND TISSUE) WERE VISIBLE. DURING THE FUNCTIONAL INVESTIGATION, THE JAW ASSEMBLIES WERE CLICKED INTO THE ANASTOMOTIC INSTRUMENT (AI) AS INTENDED. THE KNOB OF THE AI WAS ROTATED TO ENSURE THE JAW ASSEMBLY WOULD FUNCTION AS INTENDED WITHIN THE SURGICAL PROCESS. THERE WERE NO OBSERVED FUNCTIONAL MALFUNCTIONS WITH THE JAW ASSEMBLY. THE REPORTED CONDITION WAS NOT VERIFIED. A BATCH REVIEW WAS CONDUCTED AND THERE WERE NO DEVIATIONS FOUND RELATED TO THIS REPORTED CONDITION DURING THE MANUFACTURE OF THIS LOT. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT RINGS OF A 2.5MM COUPLER CAME OFF DURING USE IN AN INTRA-OP PROCEDURE. THE ISSUE WAS FURTHER DESCRIBED AS, "THE OPPOSITE RING CAME OFF WHILE ATTACHING A BLOOD VESSEL TO ONE OF THE RINGS". THERE WAS NO REPORT OF PATIENT INJURY OR MEDICAL INTERVENTION ASSOCIATED WITH THIS EVENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    365860 GEM MICROVASCULAR ANASTOMOTIC COUPLER DEVICE,ANASTOMOTIC,MICROVASCULAR MVR BAXTER HEALTHCARE CORPORATION GEM2753 ASKU 0844735002669

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown