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	02/10/2025
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 one side of a coupler came off.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.H11: the actual device was not available; however, photographs of the sample were provided for evaluation.The returned photographs were reviewed, and it was noted that there were signs of use (dried blood and tissue) which are consistent with the alleged event occurring during the surgical process.While signs of use are visible, other visual investigation into the alleged event could not be completed as the photo provided does not offer adequate details or evidence to conclude a definitive root cause.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 coupler product was returned in a petri dish with only the rings present.During investigation signs of use (dried blood and tissue) were visible.This is consistent with the reported alleged event occurring during the surgical process.The rings were no longer seated in the jaw assembly.No defects were visible on the returned rings.Visual inspection of the returned components showed no defect that would lead to the alleged event being related to the manufacturing of product.A definitive root cause for how the ring dislodged from the jaw assembly could not be determined.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: 21726177
• Report Number: 1416980-2025-01580
• Device Sequence Number: 3862461
• Product Code: MVR
• UDI-Device Identifier: 00844735002669
• UDI-Public: (01)00844735002669(10)SP24F18-2091943
• 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: SP24F18-2091943
• 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