FDA.reportPublic FDA data

MAUDE MDR 5852023

MDR report key
5852023
Report number
3005473391-2016-00099
Event key
0
Event type
3
Date of event
2016-07-07
Date received
2016-08-05
Adverse event
3
Product problem
3
Patients in event
0
Reporter occupation
2
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
1ESOPHYX2 HDODEENDOGASTRIC SOLUTIONS, INC.ODEC02042-01R2005UNKNOWNN N

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12016-08-0501. H; 2. R

Event Narratives#

N

Patient 1

THE DEVICE WAS DISCARDED PER HOSPITAL POLICY.

D

Patient 1

THE CUSTOMER REPORTED A TIF PROCEDURE WAS INITIATED WITH 6 FASTENERS SUCCESSFULLY DEPLOYED IN THE GE JUNCTION. LOSS OF INSUFFLATION WAS NOTED. OMENTUM TISSUE WAS OBSERVED ENDOSCOPICALLY AND AN EXPLORATORY LAPAROTOMY PROCEDURE WAS INITIATED TO DETERMINE CAUSE OF LOSS OF INSUFFLATION. A PERFORATION IN THE GREATER CURVATURE WAS FOUND AND RESOLVED. PHYSICIAN SPECULATES THE HELICAL TISSUE RETRACTOR EITHER PERFORATED OR TORE THE TISSUE DURING TISSUE RETRACTION. IT WAS ALSO REPORTED THAT THE PATIENTS STOMACH TISSUE APPEARED THIN AND MAY HAVE CONTRIBUTED TO THE PERFORATION. PATIENT WAS ADMITTED TO THE HOSPITAL (B)(6) 2016 AND WAS DISCHARGED (B)(6) 2016. THE PATIENT WAS SEEN (B)(6) 2016 BY THE PHYSICIAN AND IS REPORTED TO BE DOING VERY WELL.