FDA.reportPublic FDA data

MAUDE MDR 8374941

MDR report key
8374941
Report number
MW5084452
Event key
0
Event type
3
Date of event
2019-01-25
Date received
2019-02-26
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#

Report source
P
Manufacturer link flag
N

Devices#

Seq, Brand, Generic table
SeqBrandGenericManufacturerProduct codeModelCatalogLotPMA510(k)ImplantEvaluatedAvailability
1WATS3D BRUSHESOPHAGEAL BIOPSY BRUSHENDO-THERAPEUTICS, INCGEEEGD-160-006351132I N

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12019-02-2601. H

Event Narratives#

D

Patient 1

THE PATIENT, WHO HAS A HISTORY OF LONG SEGMENT BARRETT?S ESOPHAGUS (10-15 CM), UNDERWENT SURVEILLANCE WITH UPPER ENDOSCOPY WITH FORCEPS BIOPSY AND BRUSH BIOPSY. AFTER THE FORCEPS BIOPSIES WERE OBTAINED, THE BRUSH BIOPSY WAS INTRODUCED INTO THE CHANNEL OF THE ENDOSCOPE. WHILE THE PHYSICIAN HELD THE ENDOSCOPE, THE PHYSICIAN?S ASSISTANT MOVED THE BRUSH UP AND DOWN TO SAMPLE THE ESOPHAGUS. THE ESOPHAGUS WAS NOTED TO BE VERY TORTUOUS, AND AT A SEGMENT OF THE ESOPHAGUS, WHICH WAS FELT TO BE SHARPLY ANGULATED AND NOT ENTIRELY VISIBLE ON THE MONITOR, THE ESOPHAGUS WAS PERFORATED. THE PATIENT WAS ADMITTED TO THE HOSPITAL AND THE FOLLOWING DAY, THE PERFORATION WAS SURGICALLY REPAIRED. THE PATIENT RECOVERED AND WAS DISCHARGED SEVERAL DAYS LATER.