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	12/17/2024
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 the ring of a 2.5mm coupler fell out of the jaw assembly; further described as "ring fall itself".This was observed before using the device in an operation.There was no patient involvement.No additional information is available.
Additional Manufacturer Narrative
Additional information: d9, h3, h6, h11.H11: the device was received for evaluation.The 2.5mm coupler jaw assembly was returned in the coupler tray.The rings were no longer intact in the jaw assembly.Upon visual inspection, signs of use were visible on the coupler rings, such as dried blood in the mating holes.This is not consistent with the complainant¿s statement that the alleged event occurred prior to use.The returned jaw assembly was clicked into the anastomotic instrument (ai) to determine if any defects were present that may have contributed to the alleged event of ring dislodgement.The ai knob was then turned as it would be in surgical process to simulate approximating the rings.There appeared to be no defect in any portion of the jaw assembly.The product returned for the investigation, and the investigation itself, does not align with the allegation that the product ¿ring fall itself before use¿ as the customer stated.However, this complaint will be conservatively confirmed for ring dislodgement as the returned rings were no longer intact in the jaw assembly.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: 21185622
• Report Number: 1416980-2024-08033
• Device Sequence Number: 4300636
• Product Code: MVR
• UDI-Device Identifier: 00844735002669
• UDI-Public: (01)00844735002669(10)SP24E08-2068313
• Combination Product (Y/N): N
• Initial Reporter Country: TW
• 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): 02/14/2025

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: SP24E08-2068313
• 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: 12/24/2024
• Supplement Date Received by Manufacturer: 01/22/2025
• Initial Report FDA Received Date: 01/17/2025
• Supplement Report FDA Received Date: 02/14/2025
• 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