MAUDE Adverse Event Report: SYNOVIS SURGICAL INNOVATIONS GEM MICROVASCULAR ANASTOMOTIC COUPLER; GEM COUPLER

Model Number GEM2752

Device Problem Device Operates Differently Than Expected (2913)

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

Event Date 12/02/2016

Event Type  malfunction  

Manufacturer Narrative

The device history record was obtained and reviewed for lot # sp16e10-1149641.The lot passed visual and functional inspection.The coupler ring separation force results noted in the dhr for this lot were within specification.The coupler ring retention force test results were within specification.One hundred percent functional alignment testing was performed on each device during the manufacturing process.In addition, 100% visual inspection for broken or missing parts was performed.The released product met specification.Product was not returned.Physical description could not be obtained.Functional testing could not be performed.The root cause of the event could not be determined.The dhr review indicates that the lot met specification.There is no immediate evidence to support why the ring did not stay connected during use.Should additional relevant information become available, a supplemental report will be submitted.

Event Description

It was reported that after a microvascular venous anastomosis, the gem coupler opened itself.The closing of the coupler had to be completed manually with a needle holder.No adverse event has been reported.

• Brand Name: GEM MICROVASCULAR ANASTOMOTIC COUPLER
• Type of Device: GEM COUPLER
• Manufacturer (Section D): SYNOVIS SURGICAL INNOVATIONS; saint paul MN
• Manufacturer (Section G): SYNOVIS SURGICAL INNOVATIONS; 2575 university ave. w.; saint paul MN 55144
• Manufacturer Contact: 25212 w. illinois route 120; round lake, IL 60073 ; 2242702068
• MDR Report Key: 6211422
• MDR Text Key: 63475382
• Report Number: 1416980-2016-18813
• Device Sequence Number: 1
• Product Code: MVR
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: K861985
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 12/05/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/28/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/08/2021
• Device Model Number: GEM2752
• Device Lot Number: SP16E10-1149641
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/05/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/08/2016
• 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