MAUDE Adverse Event Report: BAXTER HEALTHCARE CORPORATION GEM MICROVASCULAR ANASTOMOTIC COUPLER; DEVICE,ANASTOMOTIC,MICROVASCULAR

Model Number	GEM2755
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/04/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The actual device was received for evaluation; the coupler rings, jaw assembly, and white protective holder was returned in the inner tray of the coupler packaging.Visual inspection identified signs of use (dried blood and tissue).Visual inspection of the returned jaw assembly and white protective holder showed that no damage was present that may have contributed to the reported condition.Visual inspection of the coupler rings identified misalignment in the approximated rings.A misalignment happens when the pins on the coupler ring are not properly aligned with the mating holes on the opposing ring.The visible misalignment would not allow for the process to be completed successfully.If either coupler ring had been partially dislodged from the jaw assembly in preparation for or during the surgical process, a misalignment of the coupler rings is possible.The reported condition was verified.The cause of the ring misalignment could not be determined.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.
Event or Problem Description
It was reported that the ring of a 3.5mm coupler fell off immediately after the removal of the white cap.This occurred after the coupler was attached to the anastomotic instrument; however, the coupler was not inserted.There was no report of patient injury or medical intervention associated with this event.No additional information is available.

• Brand Name: GEM MICROVASCULAR ANASTOMOTIC COUPLER
• Common Device Name: DEVICE,ANASTOMOTIC,MICROVASCULAR
• Manufacturer (Section D): BAXTER HEALTHCARE CORPORATION; deerfield IL
• Manufacturer (Section G): SYNOVIS SURGICAL INNOVATIONS; 2575 university ave w; saint paul MN 55114
• Manufacturer Contact: 25212 w. illinois route 120; round lake, IL 60073 ; 2242702068
• MDR Report Key: 20409704
• Report Number: 1416980-2024-05594
• Device Sequence Number: 15745975
• Product Code: MVR
• UDI-Device Identifier: 00844735002706
• UDI-Public: (01)00844735002706(10)SP23A23-1802434
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K861985
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 10/09/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Other
• Device Model Number: GEM2755
• Device Catalogue Number: 512100350060
• Device Lot Number: SP23A23-1802434
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/20/2024
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/11/2024
• Initial Report FDA Received Date: 10/09/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: ANASTOMOTIC INSTRUMENT
• Patient Sex: Unknown