FDA.reportPublic FDA data

MAUDE MDR 7452100

MDR report key
7452100
Report number
3005473391-2018-00110
Event key
0
Event type
3
Date of event
2018-03-29
Date received
2018-04-23
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 ST 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.ODEC02042-01R2005402429Y R

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12018-04-2301. H; 2. R

Event Narratives#

N

Patient 1

THE DEVICE WAS AVAILABLE FOR EVALUATION. AFTER CONDUCTING AN ENGINEERING EVALUATION, THE FOLLOWING ITEMS WERE NOTED: THE ENDOSCOPE RETAINER BAND FAILED DUE TO A TENSILE FRACTURE, NO SHARPS WERE FOUND ON THE DEVICE TISSUE MOLD/CHASSIS. A REVIEW OF THE PRODUCT DHR INDICATES ALL COMPONENTS USED IN THIS PRODUCT LOT ARE WITHIN SPECIFICATION AND THE DEVICE PASSED NORMAL MANUFACTURING FINAL ACCEPTANCE TESTING. NO DEFINITIVE ROOT CAUSE HAS BEEN IDENTIFIED FOR THE PERFORATION.

D

Patient 1

THE PHYSICIAN NOTED THE SILICONE ENDOSCOPE RETAINER BAND WAS BROKEN IMMEDIATELY AFTER DEVICE INSERTION AND A PORTION OF THE RETAINER BAND HAD SEPARATED FROM THE DEVICE AND WAS LAYING IN THE PATIENT'S STOMACH. THE PHYSICIAN DECIDED NOT TO RETRIEVE THE SEPARATED PORTION OF THE RETAINER BAND AND SUCCESSFULLY COMPLETED THE TIF PROCEDURE. DURING THE POST-PROCEDURE EGD, AN ESOPHAGEAL PERFORATION (THE SIZE WAS NOT REPORTED) WAS NOTED JUST PROXIMAL TO THE MOST PROXIMAL DEPLOYED FASTENER IN THE GEJ. THE PHYSICIAN SUCCESSFULLY TREATED THE PERFORATION USING A STENT AND SUTURES. THE PATIENT WAS ADMITTED TO THE HOSPITAL (B)(6) 2018 AND WAS DISCHARGED (B)(6) 2018.