MAUDE Adverse Event Report: SYNOVIS MICRO COMPANIES ALLIANCE, INC. GEM FLOW COUPLER DEVICE AND SYSTEM; DEVICE,ANASTOMOTIC,MICROVASCULAR

Model Number 3.0

Device Problem Failure to Fire (2610)

Patient Problem No Information (3190)

Event Date 09/26/2016

Event Type  malfunction  

Event Description

When surgeon was trying to use the coupler, it did not fire with this 3.0 load.The anastomosis device had fired on another load previously and after.

• Brand Name: GEM FLOW COUPLER DEVICE AND SYSTEM
• Type of Device: DEVICE,ANASTOMOTIC,MICROVASCULAR
• Manufacturer (Section D): SYNOVIS MICRO COMPANIES ALLIANCE, INC.; 439 industrial ln.; birmingham AL 35211
• MDR Report Key: 6092208
• MDR Text Key: 59586569
• Report Number: 6092208
• Device Sequence Number: 1
• Product Code: MVR
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 09/27/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/10/2016
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Expiration Date: 01/25/2021
• Device Model Number: 3.0
• Device Catalogue Number: GEMP2754
• Device Lot Number: SP16C28-1136162
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 09/27/2016
• Event Location: Hospital
• Date Report to Manufacturer: 09/27/2016
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 53 YR