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

Model Number GEM 2753-FC

Device Problem Device Operates Differently Than Expected (2913)

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

Event Date 08/17/2016

Event Type  malfunction  

Manufacturer Narrative

The device history record for this lot number was reviewed.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 manufacturing process.The ring separation force is within specification.According to the device history record, the device met specification prior to market release.One ring and the doppler probe were returned for investigation.The ring was reported as being washed at the hospital and then was returned to synovis.The ring was examined under magnification.The ring is in good condition, with exception of 3 bent pins.There are no marks on the surface and no signs of the rings being misaligned.The id of the holes are in good condition and do not show evidence that the pin of the corresponding ring was fully inserted into the full depth of the hole.It is unknown if the user fully squeezed the rings together.It is also unknown how much vessel was everted onto the pins.Lastly, it is unknown if the pins were bent during the ring approximation or during the handling after the rings were removed from the vessel.Details of the event could not be verified and the ring visually meets specifications.No further action will be taken at this time.No functional testing was performed, as only one of the flow-coupler rings was returned.The separation force between the rings could not be tested.Should additional relevant information become available, a supplemental report will be submitted.

Event Description

It was reported that the two rings of a 2.5mm gem flow coupler separated during a gracilis free slap procedure while being ejected from the anastomotic instrument.The vein anastomosis was completed by hand suture.Normal patient outcome was reported.No patient adverse effects.

• Brand Name: GEM FLOW COUPLER DEVICE AND SYSTEM
• Type of Device: ANASTOMOTIC COUPLER AND FLOW METER
• 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: 6060477
• MDR Text Key: 58525508
• Report Number: 1416980-2016-16713
• Device Sequence Number: 1
• Product Code: MVR
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: K132727
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 10/27/2016

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 Expiration Date: 04/01/2018
• Device Model Number: GEM 2753-FC
• Device Catalogue Number: 515101250010
• Device Lot Number: SP16D01-1137743
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 09/28/2016
• Initial Date FDA Received: 10/27/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/01/2016
• 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