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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device washer, cleaner, automated, endoscope
Regulation Description Endoscope and accessories.
Definition THIS AUTOMATED DEVICE IS INTENDED TO BE USED TO CLEAN ENDOSCOPES. ENDOSCOPES THAT ARE INTENDED TO BE CLEANED BY THE AUTOMATED CLEANER SYSTEM SHOULD HAVE BEEN PRE-CLEANED AND TESTED FOR LEAKS AND LUMEN OBSTRUCTIONS ACCORDING TO THE INSTRUMENT MANUFACTURER'S INSTRUCTIONS AND CURRENT PROFESSIONAL PRACTICES PRIOR TO PROCESSING IN THE SYSTEM. THE SYSTEM INCLUDES A CHEMICAL DISPENSING SYSTEM THAT METERS OUT A PREDETERMINED VOLUME OF DETERGENT DURING THE APPROPRIATE CLEANING CYCLE. THE INSTRUMENT IS PLACED IN A TRAY WITH EACH LUMEN END POSITIONED IN OPPOSITE SIDES OF THE TRAY TO ALLOW ENOUGH DETERGENT AND RINSING WATER PASS THROUGH THE LUMENS OF THE ENDOSCOPES.
Product CodeNVE
Regulation Number 876.1500
Device Class 2


Premarket Reviews
ManufacturerDecision
CUSTOM ULTRASONICS, INC.
  SUBSTANTIALLY EQUIVALENT 1
INAMED CORPORATION
  SUBSTANTIALLY EQUIVALENT 1
INTUITIVE SURGICAL, INC.
  SUBSTANTIALLY EQUIVALENT 1
LANGFORD IC SYSTEMS, INC.
  SUBSTANTIALLY EQUIVALENT 1
MEDIVATORS REPROCESSING SYSTEMS
  SUBSTANTIALLY EQUIVALENT 1

Device Problems
Fluid leak 152
Residue after decontamination 27
Other (for use when an appropriate device code cannot be identified) 25
Use of Device Issue 13
Function indicator light(s), failure of 10
Fumes or vapors 6
Unknown (for use when the device problem is not known) 3
No code available 3
Failure to pump 2
Failure to flush 2
Disinfection, inadequate/improper 2
Shock, electrical 1
Smoking 1
Device emits odor 1
Improper or incorrect procedure or method 1
Spark 1
No Known Device Problem 1
Temperature issue 1
Contamination during use 1
Total Device Problems 253

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 0 0 0 0 0 0 0 0 0 1
Class III 0 0 0 0 0 0 0 0 0 0

Recalls
Manufacturer Recall Class Date Posted
1 Custom Ultrasonics, Inc. II Jul-06-2016

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