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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BAXTER HEALTHCARE - SAINT PAUL GEM MICROVASCULAR ANASTOMOTIC COUPLER COUPLER, 2.5MM

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BAXTER HEALTHCARE - SAINT PAUL GEM MICROVASCULAR ANASTOMOTIC COUPLER COUPLER, 2.5MM Back to Search Results
Model Number GEM2753
Device Problem Device Operates Differently Than Expected (2913)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 01/30/2018
Event Type  malfunction  
Manufacturer Narrative
A supplemental report will be submitted following the completion of the complaint investigation.
 
Event Description
It was reported that a surgeon used a 2. 5mm coupler to perform the venous anastomosis during an alt flap surgery. The coupler reportedly came together as normal. However, when the coupler rings were ejected from the winged jaw assembly, the two rings separated. The rings were removed and a different coupler was used successfully. There was no harm to the patient. No additional information is available.
 
Manufacturer Narrative
A batch review was conducted and there were no deviations found related to this reported condition during the manufacture of this lot. 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 DeviceCOUPLER, 2.5MM
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 Key7290852
MDR Text Key100783472
Report Number1416980-2018-00972
Device Sequence Number1
Product Code MVR
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K861985
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 01/25/2019
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received02/22/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberGEM2753
Device Catalogue Number511100250060
Device Lot NumberSP17D07-1224616
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 Received01/02/2019
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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