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

Model Number	GEM2753
Medical Device Problem Code	Disconnection (1171)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/08/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
E1: initial reporter phone no.: (b)(6).Should additional relevant information become available, a supplemental report will be submitted.
Event or Problem Description
It was reported that the rings of a 2.5mm coupler dislodged.This was observed during assembly prior to patient use.A new device was used to complete the procedure.There was no patient involvement.No additional information is available.
Additional Manufacturer Narrative
Additional information: d4, d9, h3, h4, h6 (update codes), h11.H11: the actual device and a photograph of the sample were provided for evaluation.The coupler jaw assembly was returned with the jaw assembly, retained right ring within the inner tray, and the left ring dislodged within the inner tray.Visual inspection was performed on the returned device and dried blood on the dislodged ring and tissue on the jaw assembly spring were observed.Additionally, during the visual inspection of the provided images, there was blood visible on the anastomotic instrument (ai); however, no damage was found with either of the returned rings.During the functional investigation, the jaw assembly was clicked into an ai as intended.The knob of the ai was rotated to ensure the jaw assembly would function as intended within the surgical process.The jaw assembly closed properly; however, the jaws did not spring open after removal from the ai.The reported condition was verified.The cause of the issue 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.

• Brand Name: GEM MICROVASCULAR ANASTOMOTIC COUPLER
• Common Device Name: DEVICE,ANASTOMOTIC,MICROVASCULAR
• Manufacturer (Section D): BAXTER HEALTHCARE CORPORATION; deerfield IL
• Manufacturer (Section G): BAXTER HEALTHCARE - SAINT PAUL - MCA; 2575 university ave w.; saint paul MN 55114
• Manufacturer Contact: 25212 w. illinois route 120; round lake, IL 60073 ; 2242702068
• MDR Report Key: 24062646
• Report Number: 1416980-2026-00210
• Device Sequence Number: 18738370
• Product Code: MVR
• UDI-Device Identifier: 00844735002669
• UDI-Public: (01)00844735002669(10)SP25A06-2200874(17)291122
• Combination Product (Y/N): N
• Initial Reporter Country: TW
• PMA/510(K) Number: K861985
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 02/17/2026

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: Health Professional
• Device Model Number: GEM2753
• Device Catalogue Number: 511100250060
• Device Lot Number: SP25A06-2200874
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/18/2025
• Supplement Date Received by Manufacturer: 02/03/2026
• Initial Report FDA Received Date: 01/13/2026
• Supplement Report FDA Received Date: 02/17/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/22/2024
• 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
• Patient Sex: Unknown