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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device accessories, cleaning, for endoscope
Regulation Description Endoscope and accessories.
Product CodeFEB
Regulation Number 876.1500
Device Class 2


Premarket Reviews
ManufacturerDecision
ADVANCED STERILIZATION PRODUCTS
  SUBSTANTIALLY EQUIVALENT 4
APPLIED MEDICAL RESOURCES CORP.
  SUBSTANTIALLY EQUIVALENT 1
BIOSEARCH MEDICAL PRODUCTS, INC.
  SUBSTANTIALLY EQUIVALENT 1
CANDELA CORP.
  SUBSTANTIALLY EQUIVALENT 1
CUSTOM ULTRASONICS, INC.
  SUBSTANTIALLY EQUIVALENT 2
LANGFORD IC SYSTEMS, INC.
  SUBSTANTIALLY EQUIVALENT 2
MEDIVATORS REPROCESSING SYSTEMS
  SUBSTANTIALLY EQUIVALENT 4
MINNTECH
  SUBSTANTIALLY EQUIVALENT 1
OLYMPUS
  SUBSTANTIALLY EQUIVALENT 2
RICHARD WOLF
  SUBSTANTIALLY EQUIVALENT 1
UNITED STATES SURGICAL
  SUBSTANTIALLY EQUIVALENT 1

Device Problems
Other (for use when an appropriate device code cannot be identified) 107
No Known Device Problem 44
Unknown (for use when the device problem is not known) 35
Use of Device Issue 27
Improper or incorrect procedure or method 26
No code available 15
User used incorrect product for intended use 11
Device Cleaning Issue 9
Use of Incorrect Control Settings 9
Fumes or vapors 9
Chemical issue 8
Disinfection or Sterilization Issue at User Location 8
Fluid leak 8
Fire 6
Bacterial contamination of device 5
Device Rinsing Issue 5
Temperature issue 5
Human-Device Interface Issue 4
Maintenance does not comply to manufacturers recommendations 4
Contamination during use 4
Break 3
Leak 3
Ventilation issue in device environment 3
Chemical spillage 3
Device displays error message 2
Connection issue 2
Device disinfection or sterilization issue 2
Defective component 2
No Information 2
Insufficient heating 2
Misconnection 2
Smoking 2
Normal 2
Component(s), worn 2
Disinfection, inadequate/improper 2
Decoupling 2
Failure to disinfect 1
Crack 1
Shock, electrical 1
Grounding malfunction 1
Detachment of device component 1
Circuit Failure 1
Adaptor, failure of 1
Alarm, audible 1
Power Conditioning Issue 1
Reflux within device 1
Inadequate service 1
Inappropriate shock 1
Mislabeled 1
Instruction for use issue 1
Device maintenance issue 1
Mechanical issue 1
Misassembled 1
Pressure issue 1
Manufacturing or shipping issue associated with device 1
Material integrity issue 1
Mechanics altered 1
No flow 1
Overfill 1
Electro-static discharge 1
Metal shedding debris 1
Device misassembled during manufacturing or shipping 1
Foreign material present in device 1
Device Contamination with biological material 1
Total Device Problems 413

Recalls
  2007 2008 2009 2010 2011 2012 2013 2014 2015 2016
Class I 0 0 0 0 0 0 0 0 0 0
Class II 1 2 0 1 0 0 2 0 1 0
Class III 0 0 0 0 0 0 0 0 0 0

Recalls
Manufacturer Recall Class Date Posted
1 Advanced Sterilization Products II Jun-05-2015
2 Advanced Sterilization Products II Apr-18-2013
3 Advanced Sterilization Products II Apr-15-2013
4 Advanced Sterilization Products II Nov-07-2008
5 Advanced Sterilization Products II Aug-08-2008
6 Custom Ultrasonics, Inc. II May-04-2007
7 Minntech Corp II Aug-12-2010

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