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

Model Number GEM2754-FC

Device Problem Device Operates Differently Than Expected (2913)

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

Event Date 03/10/2015

Event Type  malfunction  

Event Description

It was reported that a gem 3.0 mm flow-coupler experienced ring separation during pharyngeal reconstruction free flap surgery after it had been placed on the patient.The flow-coupler rings were adequately removed and a new gem flow-coupler was used to complete the anastomosis.No significant additional ischemia time was reported.No adverse patient outcome was reported.

Manufacturer Narrative

The device history record for this lot number was reviewed.One hundred percent 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.The wing jaw assembly and doppler probe were returned for evaluation.The flow-coupler rings were not returned.The device was visually inspected under 10x-50x magnification.Organic material was observed on the wing jaw.The left and right wings were manually brought together.The wing jaw assembly functioned normally.The doppler probe appeared normal.The doppler probe was not functionally tested.There is no immediate evidence to support why the rings did not stay together.No additional information is available.

• 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
• Manufacturer Contact: scott johnson ; 2575 university ave.; st. paul, MN 55114-1024 ; 6517967334
• MDR Report Key: 4683912
• MDR Text Key: 5718078
• Report Number: 2183620-2015-00002
• 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: 03/10/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/10/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/06/2017
• Device Model Number: GEM2754-FC
• Device Lot Number: SPSGT15-01A0007
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/10/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/01/2015
• 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: 30 YR