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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SYNOVIS SURGICAL INNOVATIONS GEM MICROVASCULAR ANASTOMOTIC COUPLER

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SYNOVIS SURGICAL INNOVATIONS GEM MICROVASCULAR ANASTOMOTIC COUPLER Back to Search Results
Model Number GEM 2751
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 06/11/2018
Event Type  malfunction  
Manufacturer Narrative
Should additional relevant information become available, a supplemental report will be submitted. Complaint investigation methods, results and conclusion will be included in the follow-up emdr report.
 
Event Description
As reported from surgeon: the coupler was loaded without issue. When i closed it, the coupler came together but then the central piece that deploys the coupler from the hand piece did not advance properly to deploy it. I then manually pushed the coupler out of the hand piece but then the coupler came apart (this may have been from tension on the veins). I then started with a new coupler and it happened again where it did not deploy. No adverse patient event was reported. No surgical intervention was reported. No additional information is available.
 
Manufacturer Narrative
A device history record review was performed and revealed no issues that could have caused or contributed to the reported issue. The device was not received for evaluation; 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 NameGEM MICROVASCULAR ANASTOMOTIC COUPLER
Type of DeviceANASTOMOTIC COUPLER
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 Key7673763
MDR Text Key113552094
Report Number1416980-2018-04219
Device Sequence Number1
Product Code MVR
Combination Product (y/n)N
Reporter Country CodeCA
PMA/PMN Number
K861985
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation
Type of Report Initial,Followup
Report Date 08/16/2018
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received07/10/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberGEM 2751
Device Catalogue Number511100150060
Device Lot NumberSP17J23-1255038
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 Received08/16/2018
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 Initial

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