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

Model Number	GEM2753
Medical Device Problem Code	Material Twisted/Bent (2981)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/02/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the needle (pin) of a 2.5mm coupler was tilted.The issue was further described as, "the vascular anastomosis did not fit properly".This was observed during an intra-op procedure.The anastomosis was redone with a new device.There was no report of patient injury or medical intervention associated with this event.No additional information is available.
Additional Manufacturer Narrative
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.Upon receipt the approximated coupler rings were visually inspected for the reported problem.The coupler product was returned in a sterilized bag with rings joined together.There was no protective holder or jaw assembly returned with the rings.Upon inspection there were visible signs of use such as dried tissue and blood.During the inspection, a bent pin was observed on the returned coupler rings.With evidence of everted tissue visible on the returned coupler ring, it is unknown if the bent pin may have occurred during preparation for or in use during the surgical process.The reported condition was verified.The cause of the reported condition 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: 22533552
• Report Number: 1416980-2025-03807
• Device Sequence Number: 7409945
• Product Code: MVR
• UDI-Device Identifier: 00844735002669
• UDI-Public: (01)00844735002669(10)SP24H05-2116956
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• 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): 08/15/2025

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: SP24H05-2116956
• 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: 06/19/2025
• Supplement Date Received by Manufacturer: 07/21/2025
• Initial Report FDA Received Date: 07/17/2025
• Supplement Report FDA Received Date: 08/15/2025
• 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