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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, ANASTOMOTIC, MICROVASCULAR

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SYNOVIS MICRO COMPANIES ALLIANCE, INC. GEM FLOW COUPLER DEVICE, ANASTOMOTIC, MICROVASCULAR Back to Search Results
Model Number GEM2753
Device Problem Device Operates Differently Than Expected (2913)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 05/04/2018
Event Type  malfunction  
Event Description
During a diep flap reconstruction procedure, dr. Was bringing a gem2753 device under the microscope and it failed before application. No injury occurred. Device was removed from field and replaced with another one.
 
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Brand NameGEM FLOW COUPLER
Type of DeviceDEVICE, ANASTOMOTIC, MICROVASCULAR
Manufacturer (Section D)
SYNOVIS MICRO COMPANIES ALLIANCE, INC.
439 industrial lane
birmingham AL 35211
MDR Report Key7530699
MDR Text Key108806432
Report Number7530699
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 05/07/2018
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received05/21/2018
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberGEM2753
Device Catalogue Number511100250060
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional?
Was the Report Sent to FDA? Yes
Date Report Sent to FDA05/07/2018
Event Location Hospital
Date Report to Manufacturer05/07/2018
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? No Answer Provided
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage

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