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

Model Number	GEM2752 I
Medical Device Problem Code	Material Twisted/Bent (2981)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
D4: the lot # and expiration date were not included in the udi # as the lot was not recognized in the system.Should additional relevant information become available, a supplemental report will be submitted.
Event or Problem Description
It was reported that a 2.0mm coupler had a bent pin.The bent pin was visualized prior to patient use.There was no patient involvement.No additional information is available.
Additional Manufacturer Narrative
Additional information was added to d4 expiration date, d4 udi #, h4, h6 and h11: h11: the actual device was not available; however, a photograph of the sample was provided for evaluation.A visual inspection was performed, and a slight bend in a pin on the right coupler ring was observed.The reported condition was verified.The cause of the 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.
Additional Manufacturer Narrative
Additional information was added to d9, h3, and h6.H11: the device was received for evaluation.No signs of use were visible on the coupler rings, which is consistent with the event occurring before use.The 2.0mm coupler was returned in the original tray without the white protective holder.During visual inspection, no bent pin was visible on the device.When the rings where approximated with the anastomotic instrument, the rings aligned properly and were able to be approximated.The reported condition was not verified in the actual sample; however, the returned photograph showed a slight bend in a pin on the right coupler ring, therefore, the reported condition was verified in the returned photograph.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: 21061061
• Report Number: 1416980-2024-07767
• Device Sequence Number: 21022210
• Product Code: MVR
• UDI-Device Identifier: 00844735002638
• UDI-Public: (01)00844735002638(10)SP23H17-1922200(17)280712
• Combination Product (Y/N): N
• Initial Reporter Country: SP
• 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,Followup
• Report Date (Section B): 11/05/2025

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: Other
• Device Model Number: GEM2752 I
• Device Catalogue Number: 511100200010
• Device Lot Number: SP23H17-1922200
• 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: 12/04/2024
• Supplement Date Received by Manufacturer: 01/22/2025; 10/10/2025
• Initial Report FDA Received Date: 01/02/2025
• Supplement Report FDA Received Date: 02/13/2025; 11/05/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/12/2023
• 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