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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
Unknown (for use when the device problem is not known) 35
No Known Device Problem 35
Use of Device Issue 26
Improper or incorrect procedure or method 21
No code available 15
User used incorrect product for intended use 11
Use of Incorrect Control Settings 9
Fluid leak 8
Fumes or vapors 8
Chemical issue 8
Disinfection or Sterilization Issue at User Location 6
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
Device Cleaning Issue 4
Contamination during use 4
Break 3
Chemical spillage 3
Ventilation issue in device environment 3
No Information 2
Device displays error message 2
Defective component 2
Connection issue 2
Device disinfection or sterilization issue 2
Component(s), worn 2
Decoupling 2
Disinfection, inadequate/improper 2
Insufficient heating 2
Smoking 2
Normal 2
Misconnection 2
Mislabeled 1
Grounding malfunction 1
Reflux within device 1
Inadequate service 1
Inappropriate shock 1
Power Conditioning Issue 1
Electro-static discharge 1
Metal shedding debris 1
Instruction for use issue 1
Leak 1
Device maintenance issue 1
Mechanical issue 1
Misassembled 1
Shock, electrical 1
Crack 1
Detachment of device component 1
Circuit Failure 1
Adaptor, failure of 1
Alarm, audible 1
Device misassembled during manufacturing or shipping 1
Foreign material present in device 1
Device Contamination with biological material 1
Manufacturing or shipping issue associated with device 1
Material integrity issue 1
Mechanics altered 1
No flow 1
Overfill 1
Pressure issue 1
Total Device Problems 387

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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