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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 GEM2753
Device Problem Device Operates Differently Than Expected (2913)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 05/29/2018
Event Type  malfunction  
Manufacturer Narrative
(b)(6). Should additional relevant information become available, a supplemental report will be submitted.
 
Event Description
It was reported that during a bilateral deep inferior epigastric procedure (diep) flap reconstruction procedure, the physician was bringing a gm2753 device under the microscope and it failed before application. The device was removed from the field and replaced with another one. There was no patient injury or medical intervention associated with this event. No additional information is available.
 
Manufacturer Narrative
The device was received for evaluation without the holder and packaging components. Visual inspection revealed that the right ring was seated in the jaw while the left ring was missing. The right ring was inspected with the naked eye and was found to be correctly seated and undamaged. The cause of the missing left ring was not determined. 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 Key7631897
MDR Text Key112165269
Report Number1416980-2018-03796
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 Other Health Care Professional
Type of Report Initial,Followup
Report Date 11/14/2018
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received06/22/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberGEM2753
Device Catalogue Number511100250060
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer11/02/2018
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received11/08/2018
Was Device Evaluated by Manufacturer? Yes
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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