FDA.reportPublic FDA data

MAUDE MDR 6724062

MDR report key
6724062
Report number
3005921952-2017-00001
Event key
0
Event type
3
Date of event
2017-06-23
Date received
2017-07-19
Adverse event
3
Product problem
3
Patients in event
0
Reporter occupation
0
Health professional
0
Initial report to FDA
0
Event location
3

Manufacturer Contact#

Contact
MR PAUL ZADOW
Address
3 CHARLES STREET ALLENBY GARDENS, 5009 AS
Report source
M
Manufacturer link flag
Y

Devices#

Seq, Brand, Generic table
SeqBrandGenericManufacturerProduct codeModelCatalogLotPMA510(k)ImplantEvaluatedAvailability
1RBI2RBI2 SUCTION RECTAL BIOPSY SYSTEMFCKY *

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12017-07-1901. R

Event Narratives#

N

Patient 1

THIS REPORT RELATES TO NOTICE OF INCIDENTS FROM A SINGLE USER AT A HOSPITAL IN THE (B)(6). THE USER FAILED TO FULLY DEPRESS THE TRIGGER TO ACTIVATE THE BLADE AS PER DESCRIBED IN THE PRODUCT IFU SUPPLIED WITH THE DEVICE. THIS DEVICE HAS BEEN INCIDENT FREE WITH ALL OTHER USERS AT THE HOSPITAL SINCE ITS ORIGINAL PURCHASE 11 YEARS PRIOR. FURTHER TECHNICAL TRAINING HAS BEEN OFFERED TO THE INDIVIDUAL AND OTHER HOSPITAL STAFF AND THIS IS CURRENTLY BEING CONDUCTED. THE DEVICE REQUIRED MINOR INTERVENTION FOR REMOVAL OF THE DEVICE FROM THE SUBMUCOSA TISSUE. THE INCIDENTS DID NOT CAUSE ANY SERIOUS LONG TERM INJURY TO THE PATIENTS.

D

Patient 1

SUBMUCOSA TISSUE WEDGED BETWEEN CUTTING BLADE DUE TO USER NOT FOLLOWING INSTRUCTIONS FOR USE TO FULLY DEPRESS THE DEVICE TRIGGER.