MAUDE Adverse Event Report: SYNOVIS SURGICAL INNOVATIONS COUPLER,3.0MM; GEM MICROVASCULAR ANASTOMOTIC COUPLER

Model Number GEM2754

Device Problem Device Operates Differently Than Expected (2913)

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

Event Date 10/13/2016

Event Type  malfunction  

Manufacturer Narrative

Dhr review was completed.No irregularities were found when reviewing supplier records.The coupler separation force and the pre-sterilization ring retention specification for coupler is within specification.100% 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 in the wing jaw during use.Should additional relevant information become available, a supplemental report will be submitted.

Event Description

It was reported that rings of two different 3.0mm gem coupler devices dislodged from the wing jaw assembly, both on the right side.The event occurred during occurred of the vein for latissimus free flap to leg.Both couplers were discarded.The surgeon used a 2.5mm gem coupler to complete the anastomosis.The patient is reported to be doing well.No patient adverse event was reported.

• Brand Name: COUPLER,3.0MM
• Type of Device: GEM MICROVASCULAR ANASTOMOTIC 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: 6104987
• MDR Text Key: 59969474
• Report Number: 1416980-2016-17331
• 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: Physician
• Type of Report: Initial
• Report Date: 11/15/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/15/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/08/2021
• Device Model Number: GEM2754
• Device Catalogue Number: 511100300060
• Device Lot Number: SP16H04-1171508
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/18/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/08/2016
• 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
• Patient Age: 63 YR