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	01/28/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
D4: unique identifier (udi) #: the expiration date is not available for this product; therefore, the expiration date portion of the udi was not included in the mdr submission.Should additional relevant information become available, a supplemental report will be submitted.
Event or Problem Description
It was reported that a coupler ring was detached.This occurred while preparing to attach the coupler to the main unit before surgery.There was no patient involvement.No additional information is available.
Additional Manufacturer Narrative
Additional information was added to h6 and h11: h11: the actual device was not available; however, a photograph of the sample was provided for evaluation.The returned photograph was reviewed, and one ring dislodged from the jaw assembly was observed.The reported condition was verified.The cause of the condition could not be determined.A device history review revealed no issues that could have caused or contributed to the reported issue.Should additional relevant information become available, a supplemental report will be submitted.
Additional Manufacturer Narrative
Additional information was added to d9, h3, and h6.H11: the device was received for evaluation.The 2.5mm coupler jaw assembly were returned with the left ring seated in the jaw assembly.During visual inspection, signs of use were visible such as dried blood which is consistent with the complainant¿s statement.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, however, visual inspection confirmed that the left ring was dislodged from the jaw assembly.The reported condition was verified.The cause of the reported condition could not be determined.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: 21725643
• Report Number: 1416980-2025-01578
• Device Sequence Number: 17095943
• Product Code: MVR
• UDI-Device Identifier: 00844735002669
• UDI-Public: (01)00844735002669(10)SP24D29-2062965
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: NI
• 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,Followup
• Report Date (Section B): 07/21/2025

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: SP24D29-2062965
• 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: 02/28/2025
• Supplement Date Received by Manufacturer: 04/14/2025; 06/23/2025
• Initial Report FDA Received Date: 03/28/2025
• Supplement Report FDA Received Date: 05/01/2025; 07/21/2025
• 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
• Patient Sex: Unknown