FDA.reportPublic FDA data

MAUDE MDR 5502996

MDR report key
5502996
Report number
3005473391-2016-00096
Event key
0
Event type
3
Date of event
2016-02-22
Date received
2016-03-15
Adverse event
3
Product problem
3
Patients in event
0
Reporter occupation
1
Health professional
3
Initial report to FDA
3
Event location
3

Manufacturer Contact#

Contact
MR. JAMES BROOKS
Address
18109 NE 76TH STREET SUITE 100 REDMOND WA 98052 US
Phone
425-425-4253
Report source
M
Manufacturer link flag
Y

Devices#

Seq, Brand, Generic table
SeqBrandGenericManufacturerProduct codeModelCatalogLotPMA510(k)ImplantEvaluatedAvailability
1ESOPHYX ZODEENDOGASTRIC SOLUTIONS, INC.ODEC02162-01R2006NOT REPORTEDN N

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12016-03-1501. H

Event Narratives#

N

Patient 1

PROCEDURE WAS PERFORMED SUCCESSFULLY AND THE DEVICE WAS DISCARDED PER HOSPITAL POLICY. THERE WAS NO ALLEGATION OF A PRODUCT MALFUNCTION.

D

Patient 1

A SUCCESSFUL TIF PROCEDURE WAS PERFORMED ON (B)(6) 2016 AND THE DEVICE WAS DISPOSED OF PER HOSPITAL POLICY. TWO DAYS LATER THE PHYSICIAN REPORTED TO THE EGS SALES REPRESENTATIVE THE PATIENT WAS READMITTED WITH CHEST PAIN. IT WAS POSTULATED A SMALL LEAK DEVELOPED DURING THE PROCEDURE, ALLOWING PROCEDURE INSUFFLATION GAS INTO THE MEDIASTINUM. A CT SCAN SUPPORTED THIS AS IT DID NOT SHOW ANY ANY PLEURAL EFFUSION OR SUB-DIAPHRAGM AIR AND INDICATED ANY LEAK HAD RESOLVED ON ITS OWN. EXPERIENCE HAS SHOWN THE PROCEDURE GAS USED WILL ABSORB AFTER TWO TO THREE DAYS IN MOST CASES. THE PHYSICIAN TOOK A POSITION OF EXPECTANT SURVEILLANCE WITH NO INTERVENTION. A FEW DAYS LATER THE PHYSICIAN REPORTED THE PATIENT WAS DOING WELL. THE GAS HAD ABSORBED AND THE PATIENT WAS DISCHARGED.