MAUDE Adverse Event Report: BAXTER HEALTHCARE - SAINT PAUL GEM MICROVASCULAR ANASTOMOTIC COUPLER COUPLER, 2.5MM

Model Number GEM2753

Device Problem Device Operates Differently Than Expected (2913)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 01/30/2018

Event Type  malfunction  

Manufacturer Narrative

A supplemental report will be submitted following the completion of the complaint investigation.

Event Description

It was reported that a surgeon used a 2. 5mm coupler to perform the venous anastomosis during an alt flap surgery. The coupler reportedly came together as normal. However, when the coupler rings were ejected from the winged jaw assembly, the two rings separated. The rings were removed and a different coupler was used successfully. There was no harm to the patient. No additional information is available.

Manufacturer Narrative

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
• Type of Device: COUPLER, 2.5MM
• Manufacturer (Section D): BAXTER HEALTHCARE - SAINT PAUL; saint paul MN
• Manufacturer (Section G): BAXTER HEALTHCARE - SAINT PAUL; 2575 university ave w; saint paul MN 55114
• Manufacturer Contact: 25212 w. illinois route 120; round lake, IL 60073 ; 2242702068
• MDR Report Key: 7290852
• MDR Text Key: 100783472
• Report Number: 1416980-2018-00972
• Device Sequence Number: 1
• Product Code: MVR
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K861985
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health

Reporter Occupation

• Type of Report: Initial,Followup
• Report Date: 01/25/2019

1 Device was Involved in the Event

0 Patients were Involved in the Event:

• Date FDA Received: 02/22/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes

Device Operator

• Device Model Number: GEM2753
• Device Catalogue Number: 511100250060
• Device Lot Number: SP17D07-1224616
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes

Was the Report Sent to FDA?

• Event Location: No Information
• Date Manufacturer Received: 01/02/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial