FDA.reportPublic FDA data

MAUDE MDR 2195159

MDR report key
2195159
Report number
1033554-2011-00003
Event key
0
Event type
3
Date of event
2010-12-03
Date received
2011-07-13
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#

Address
200 DEBUSK LANE POWELL TN 37849 US
Phone
865-865-8659
Report source
M
Manufacturer link flag
Y

Devices#

Seq, Brand, Generic table
SeqBrandGenericManufacturerProduct codeModelCatalogLotPMA510(k)ImplantEvaluatedAvailability
1DEROYAL INSUFFLATION TUBING WITH .3 MICRO FIT.TUBING WITH FILTER, INSUFFLATIONDEROYAL INDUSTRIES, INC.NKC28-021124085731Y N

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12011-07-1301. O

Event Narratives#

D

Patient 1

SURGEONS REPEATEDLY ARE COMPLAINING THAT THE TUBING IS EXTREMELY SLOW TO INSUFFLATE. COMPLAINTS OF DEFECTIVE PRODUCT AND MAYBE THE FILTERS ARE BAD. THIS HAS OCCURRED DURING MULTIPLE CASES OF LAPAROSCOPIC SURGERY. INSUFFLATING THE ABDOMEN USING THIS TUBING WAS VERY SLOW. THIS SLOWED THE PROGRESS OF SURGERY. AT LEAST SIX TUBINGS WERE PULLED AND DEMONSTRATED THE SAME PROBLEM.

N

Patient 1

COMPLETED WITH INFO PROVIDED BY THE USER FACILITY. AFTER ANALYSIS OF THE DEVICE COMPONENTS AND OTHER POSSIBLE ROOT CAUSES, IT WAS DETERMINED THAT THE INSUFFLATION TUBING REPORTED MAY BECOME OCCLUDED DUE TO HOUSING MATERIAL. THE PLASTICIZER MAY MIGRATE FROM THE TUBING INTO THE FILTER HOUSING CAUSING AN OCCLUSION. HEAT HAS ALSO BEEN DETERMINED TO PRECIPITATE THE OCCLUSION. THROUGH EXTENSIVE TESTING AND RESEARCH, A DECISION WAS MADE TO CHANGE THE FILTER HOUSING MATERIAL TO (B)(4). (B)(4) IS A STRONGER, HIGHER IMPACT AND MORE CHEMICALLY RESISTANT MATERIAL. IT IS ALSO LESS AFFECTED BY HIGHER TEMPERATURES. WE ARE CONFIDENT THIS ACTION HAS ELIMINATED THE TUBING ISSUE.