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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SYNOVIS SURGICAL INNOVATIONS FLOW COUPLER DEVICE, ANASTOMOTIC, MICROVASCULAR

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SYNOVIS SURGICAL INNOVATIONS FLOW COUPLER DEVICE, ANASTOMOTIC, MICROVASCULAR Back to Search Results
Model Number GEM2754-FC
Device Problem Detachment of Device or Device Component (2907)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 07/23/2018
Event Type  malfunction  
Manufacturer Narrative
Should additional relevant information become available, a supplemental report will be submitted.
 
Event Description
It was reported that a 3. 0mm gem flow coupler was faulty. It was further reported that the rings would just fall out of the device disposable piece. There was no report of patient injury or medical intervention associated with this event. No additional information is available.
 
Manufacturer Narrative
A device history review revealed no issues that could have caused or contributed to the reported issue. The device was not returned; therefore, a device analysis could not be completed. Should additional relevant information become available, a supplemental report will be submitted.
 
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Brand NameFLOW COUPLER
Type of DeviceDEVICE, ANASTOMOTIC, MICROVASCULAR
Manufacturer (Section D)
SYNOVIS SURGICAL INNOVATIONS
saint paul MN
Manufacturer (Section G)
SYNOVIS SURGICAL INNOVATIONS
2575 university ave. w
saint paul MN 55114
Manufacturer Contact
25212 w. illinois route 120
round lake, IL 60073
2242702068
MDR Report Key7838159
MDR Text Key118943916
Report Number1416980-2018-05545
Device Sequence Number1
Product Code MVR
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K132727
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Reporter Occupation
Type of Report Initial,Followup
Report Date 10/05/2018
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received08/31/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Other
Device Expiration Date07/27/2021
Device Model NumberGEM2754-FC
Device Catalogue Number515101300010
Device Lot NumberSP17H23-1245890
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received10/04/2018
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage

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