• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

New Search Show TPLC since Back To Search Results
Device lavage, jet
Regulation Description Jet lavage.
Product CodeFQH
Regulation Number 880.5475
Device Class 2


Premarket Reviews
ManufacturerDecision
NEXT SCIENCE, LLC
  SUBSTANTIALLY EQUIVALENT 1
SMITH & NEPHEW, INC.
  SUBSTANTIALLY EQUIVALENT 1

Device Problems
Expulsion 80
Biocompatibility 67
Device Contaminated during manufacture or shipping 61
Leak / Splash 59
Overheating of Device 52
Mechanical Problem 44
Fluid Leak 42
Break 42
Battery Problem 40
Disconnection 32
Difficult to Insert 31
Detachment of Device or device Component 28
Device Contamination with Chemical or Other Material 25
Appropriate Term/Code Not Available 24
Smoking 23
Corroded 21
Delivered as Unsterile Product 18
No Flow 16
Disassembly 15
Fracture 14
Melted 13
Device Operates Differently Than Expected 12
Adverse Event Without Identified Device or Use Problem 12
Defective Component 12
Electrical Power Problem 10
Inaccurate Delivery 9
Electrical /Electronic Property Problem 9
Defective Device 8
Insufficient Information 8
Temperature Problem 7
Failure to Power Up 6
Material Deformation 6
Use of Device Problem 5
Device Emits Odor 5
Noise, Audible 5
Burst Container or Vessel 4
Connection Problem 4
Difficult to Remove 4
Inability to Irrigate 3
Decrease in Pressure 3
Device Dislodged or Dislocated 3
Improper Flow or Infusion 3
Power Problem 3
Detachment Of Device Component 3
No Pressure 3
Packaging Problem 2
Material Rupture 2
Failure to Prime 2
Battery 2
Excessive Heating 2
Loss of Power 2
Handpiece 2
Improper or Incorrect Procedure or Method 2
Pressure Problem 2
Inaccurate Flow rate 2
Pumping Stopped 2
Suction Problem 2
Obstruction of Flow 1
No Device Output 1
Off-Label Use 1
Material Frayed 1
Failure to Charge 1
Defective Alarm 1
Thermal Decomposition of Device 1
Explosion 1
Separation Problem 1
Scratched Material 1
Misassembled During Installation 1
Device Packaging Compromised 1
Loose or Intermittent Connection 1
Unsealed Device Packaging 1
Charred 1
Circuit Failure 1
Sparking 1
Chemical Spillage 1
Contamination / decontamination Problem 1
No Apparent Adverse Event 1
Particulates 1
Increase in Pressure 1
Device, or device fragments remain in patient 1
Shipping Damage or Problem 1
Moisture Damage 1
Restricted Flow rate 1
Device Alarm System 1
Blocked Connection 1
Device Fell 1
Accessory Incompatible 1
Material Disintegration 1
Power Conditioning Problem 1
Application Program Problem 1
Application Security Problem 1
Premature Discharge of Battery 1
Device Reprocessing Problem 1
Improper Device Output 1
Component Misassembled 1
Positioning Problem 1
Device Stops Intermittently 1
Tear, Rip or Hole in Device Packaging 1
Loss of or Failure to Bond 1
Crack 1
Total Device Problems 961

Recalls
Manufacturer Recall Class Date Posted
1 EXP Pharmaceutical Services Corp II Jul-24-2015
2 IrriMAX Corporation II Oct-24-2019
3 Maquet Cardiovascular, LLC II Mar-07-2019
4 Medex Cardio-Pulmonary Inc., d.b.a. Smiths Medical Company II Nov-20-2018
5 Stryker Instruments Div. of Stryker Corporation II Mar-28-2018
6 Stryker Instruments Div. of Stryker Corporation II Jul-13-2015

-
-