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

Model Number	GEM2752
Medical Device Problem Code	Material Twisted/Bent (2981)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/27/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
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; further described as "one of the prongs was bent".This was observed during inspection, before use in a bilateral breast diep flap reconstruction procedure.A new coupler was used to continue with the preparation.There was no patient involvement.No additional information is available.
Additional Manufacturer Narrative
Additional information: h6, 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.

• 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: 21774409
• Report Number: 1416980-2025-01876
• Device Sequence Number: 15475595
• Product Code: MVR
• UDI-Device Identifier: 00844735002645
• UDI-Public: (01)00844735002645(10)SP24B26-2027706
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• Initial Reporter Country: US
• 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: Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 05/05/2025

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: Health Professional
• Device Model Number: GEM2752
• Device Catalogue Number: 511100200060
• Device Lot Number: SP24B26-2027706
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/05/2025
• Supplement Date Received by Manufacturer: 04/14/2025
• Initial Report FDA Received Date: 04/04/2025
• Supplement Report FDA Received Date: 05/05/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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