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

Model Number	GEM2752
Medical Device Problem Code	Disconnection (1171)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/20/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the ring of a 2.0mm coupler fell off.The coupler was loaded into the applicator correctly; however, when the guard was removed one of the rings just fell off.This occurred during use.There was no report of patient injury or medical intervention associated with this event.No additional information is available.
Additional Manufacturer Narrative
E1: initial reporter postal code: (b)(6).Should additional relevant information become available, a supplemental report will be submitted.
Additional Manufacturer Narrative
Additional information: h6 (update codes), h11.H11: a batch review was conducted and there were no deviations found related to this reported condition during the manufacture of this lot.The device was not received for evaluation; therefore, a device analysis could not be completed.Should additional relevant information become available, a supplemental report will be submitted.
Additional Manufacturer Narrative
Additional information: d4, d9, h3, h6 (update codes), h11.H11: the device was received for evaluation.Visual inspection was performed which showed that the wing was broken off.The reported condition was verified.The cause of the issue 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): SYNOVIS SURGICAL INNOVATIONS; 2575 university ave w; saint paul MN 55114
• Manufacturer Contact: 25212 w. illinois route 120; round lake, IL 60073 ; 2242702068
• MDR Report Key: 21861845
• Report Number: 1416980-2025-02311
• Device Sequence Number: 11910123
• Product Code: MVR
• UDI-Device Identifier: 00844735002645
• UDI-Public: (01)00844735002645(10)SP24A18-2005082(17)281207
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• 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,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 08/11/2025

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: GEM2752
• Device Catalogue Number: 511100200060
• Device Lot Number: SP24A18-2005082
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/20/2025
• Supplement Date Received by Manufacturer: 05/02/2025; 07/15/2025
• Initial Report FDA Received Date: 04/17/2025
• Supplement Report FDA Received Date: 05/22/2025; 08/11/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/07/2023
• 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
• Concomitant Medical Products and Therapy/Usage Dates: ANASTOMOTIC INSTRUMENT
• Patient Sex: Unknown