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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BAXTER HEALTHCARE - SAINT PAUL GEM MICROVASCULAR ANASTOMOTIC COUPLER

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BAXTER HEALTHCARE - SAINT PAUL GEM MICROVASCULAR ANASTOMOTIC COUPLER Back to Search Results
Model Number GEM 2753
Device Problem Device Operates Differently Than Expected (2913)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 04/19/2018
Event Type  malfunction  
Manufacturer Narrative
Should additional relevant information become available, a supplemental report will be submitted.
 
Event Description
It was reported that a 2. 5mm gem coupler would not anastomose the vessel completely. The backup 2. 5mm coupler was opened and implanted successfully. There was no report of patient injury or medical intervention associated with this event. No additional information is available.
 
Manufacturer Narrative
The device was not returned and the lot number is unknown; therefore, a device analysis could not be completed. Too much tissue in the ring and/or surgeon does not pinch assembly together with a hemostat is the most likely cause of the event not closing properly. The occurrence rate of not closing properly is low and meets the anticipated rate in the risk file. There was no harm to the patient. No additional action will be taken. Future events will be monitored. 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)
BAXTER HEALTHCARE - SAINT PAUL
saint paul MN
Manufacturer (Section G)
BAXTER HEALTHCARE - SAINT PAUL
2575 university ave w
saint paul MN 55114
Manufacturer Contact
25212 w. illinois route 120
round lake, IL 60073
2242702068
MDR Report Key7573522
MDR Text Key110368218
Report Number1416980-2018-03438
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 08/06/2018
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received06/06/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberGEM 2753
Device Catalogue Number5111-00250-060
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received07/09/2018
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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