MAUDE Adverse Event Report: SYNOVIS SURGICAL INNOVATIONS GEM FLOW COUPLER DEVICE AND SYSTEM; ANASTOMOTIC COUPLER AND FLOW METER

Model Number GEM2752-FC

Device Problems Device Operates Differently Than Expected (2913); Output Problem (3005)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 11/10/2014

Event Type  malfunction  

Manufacturer Narrative

The product is not available for evaluation.A review of the device history record is not possible because the lot number is not known; 100% functional alignment testing is performed on each device and 100% visual inspection for broken or missing parts and pin alignment is performed on each assembly during the mfg process; 100% functional signal testing of the doppler probe is also performed after assembly into the ring, just prior to packaging in the tray.

Event Description

It was reported that a gem 2.0mm flow-coupler was implanted on the internal mammary vein of the left breast during a free flap breast reconstruction procedure.The surgeon reported a doppler signal was audible before the artery clamps were removed.The surgeon reported the same doppler signal was audible after the clamps were removed from the artery.The surgery was continued without further incident.The flap was healthy and the pt recovered without any reported complications or adverse outcomes.

• Brand Name: GEM FLOW COUPLER DEVICE AND SYSTEM
• Type of Device: ANASTOMOTIC COUPLER AND FLOW METER
• Manufacturer (Section D): SYNOVIS SURGICAL INNOVATIONS; 2575 university ave.; st. paul MN 55114 1024
• Manufacturer (Section G): SYNOVIS SURGICAL INNOVATIONS; 2575 university ave.; st. paul MN 55114 1024
• Manufacturer Contact: scott johnson ; 2575 university ave.; st. paul, MN 55114-1024 ; 6517967334
• MDR Report Key: 14755905
• MDR Text Key: 295127739
• Report Number: 2183620-2014-00023
• Device Sequence Number: 1
• Product Code: DPW
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K132727
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 11/10/2014

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
• Device Operator: Health Professional
• Device Model Number: GEM2752-FC
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/10/2014
• Initial Date FDA Received: 12/11/2014
• 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
• Patient Sequence Number: 1
• Patient Sex: Female