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

Device Problem Device Dislodged or Dislocated (2923)

Patient Problem Occlusion (1984)

Event Type  Injury  

Event Description

It was reported that a gem microvascular anastomotic flow-coupler was implanted during a perforator flap case.Venous occlusion was reported post-operatively.The patient was re-operated and the flow-coupler doppler probe was reportedly found dislodged from the flow-coupler.The doppler probe wire was reported to be against the vessel in a compromising fashion.It was reported that the flap was salvaged.The probe wire was not retained by the hospital.No additional information is available and the physician does not recall specific details.

Manufacturer Narrative

The product is not available for evaluation.A review of the device history record was not possible since the lot number was unavailable.There is no information that indicates that the product failed to meet specification and no information to indicate a root cause.The product risk assessment evaluates the risk and causes of the probe becoming dislodged from the flow-coupler ring.There is no effect for the probe compromising the vessel.If the probe wire becomes dislodged from the device, there should no longer be any force applied to the vessel.

• 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. w.; st. paul MN 55114
• Manufacturer Contact: scott johnson ; 2575 university ave. w.; st. paul, MN 55114-1024 ; 6517967334
• MDR Report Key: 4029682
• MDR Text Key: 15912083
• Report Number: 2183620-2014-00011
• Device Sequence Number: 1
• Product Code: MVR
• 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: 07/07/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 08/01/2014
• 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 Outcome(s): Required Intervention