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	01/13/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Additional information: d4 expiration date and udi #, d9, e1, h3, h4, h6 (update codes), h11.Correction: d4: model #, g4: pma/510k #.E1: initial reporter phone no.: (b)(6).H11: the device was received for evaluation.The coupler jaw assembly was returned with the jaw assembly, holder, and dislodged rings within the opened inner and outer trays.During visual inspection, the coupler assembly and holder showed no signs of damage.There was a bent pin on one ring and evidence of patient use, such as dried blood or tissue.During the functional investigation, the jaw assembly was clicked into an 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.The jaw assembly closed properly, and the jaws sprung open after removal from the ai as expected.The reported condition was verified.The cause of the ring dislodgement and bent pin 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.
Additional Manufacturer Narrative
Should additional relevant information become available, a supplemental report will be submitted.
Event or Problem Description
It was reported that there was a dislodgment of the ring of a microvascular anastomotic coupler device.After assembly of the coupling system and prior to performing the anastomosis, one of the rings became dislodged from the instrument, which prevented successful anastomosis.The rings were then safely removed, and the procedure was subsequently completed using a new, identical device.There was no patient involvement.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): BAXTER HEALTHCARE - SAINT PAUL - MCA; 2575 university ave w.; saint paul MN 55114
• Manufacturer Contact: 25212 w. illinois route 120; round lake, IL 60073 ; 2242705355
• MDR Report Key: 24421446
• Report Number: 1416980-2026-00677
• Device Sequence Number: 13406061
• Product Code: MVR
• UDI-Device Identifier: 00844735002669
• UDI-Public: (01)00844735002669(17)300210(10)SP25D02-2254357
• 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): 03/25/2026

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: SP25D02-2254357
• 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: 01/26/2026
• Supplement Date Received by Manufacturer: 03/06/2026
• Initial Report FDA Received Date: 02/23/2026
• Supplement Report FDA Received Date: 03/25/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/10/2025
• 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