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U.S. Department of Health and Human Services

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

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SYNOVIS MICRO COMPANIES ALLIANCE, INC. GEM FLOW COUPLER DEVICE AND SYSTEM DEVICE,ANASTOMOTIC,MICROVASCULAR Back to Search Results
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.
 
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Brand NameGEM FLOW COUPLER DEVICE AND SYSTEM
Type of DeviceDEVICE,ANASTOMOTIC,MICROVASCULAR
Manufacturer (Section D)
SYNOVIS MICRO COMPANIES ALLIANCE, INC.
439 industrial ln.
birmingham AL 35211
MDR Report Key6092208
MDR Text Key59586569
Report Number6092208
Device Sequence Number1
Product Code MVR
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source User Facility
Reporter Occupation
Type of Report Initial
Report Date 09/27/2016
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received11/10/2016
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date01/25/2021
Device Model Number3.0
Device Catalogue NumberGEMP2754
Device Lot NumberSP16C28-1136162
Was Device Available for Evaluation? No Answer Provided
Is the Reporter a Health Professional?
Was the Report Sent to FDA? Yes
Date Report Sent to FDA09/27/2016
Event Location Hospital
Date Report to Manufacturer09/27/2016
Was Device Evaluated by Manufacturer? No Answer Provided
Is the Device Single Use? No Answer Provided
Is This a Reprocessed and Reused Single-Use Device?
Type of Device Usage

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