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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device electrode, ph, stomach
Regulation Description Stomach pH electrode.
Product CodeFFT
Regulation Number 876.1400
Device Class 1


Premarket Reviews
ManufacturerDecision
BIOSEARCH MEDICAL PRODUCTS, INC.
  SUBSTANTIALLY EQUIVALENT 2
DATEX-OHMEDA, INC.
  SUBSTANTIALLY EQUIVALENT 1
GIVEN IMAGING
  SUBSTANTIALLY EQUIVALENT 1
VASCULAR TECHNOLOGY INCORPORATED
  SUBSTANTIALLY EQUIVALENT 1

Device Problems
Failure to deploy 1015
Other (for use when an appropriate device code cannot be identified) 612
Failure to Adhere or Bond 352
Handpiece break 123
Unknown (for use when the device problem is not known) 68
Failure to advance 65
Difficult to deploy 43
No Known Device Problem 30
Device operates differently than expected 30
Communication or transmission issue 27
Detachment of device or device component 11
Detachment of device component 8
Data Issue 7
Invalid sensing 6
Incorrect or inadequate result 6
Entrapment of device or device component 5
Failure to transmit record 5
Connection issue 4
Loss of or failure to bond 4
Premature deployment 4
High pH 4
Device Issue 4
Failure to separate 4
Implant, removal of 3
Difficult to position 3
Output issue 3
Calibration error 3
Explanted 3
No display or display failure 3
Improper or incorrect procedure or method 3
Difficult to remove 3
Device, or device fragments remain in patient 2
Bent 2
Power source issue 2
Deployment issue 2
High Readings 2
Device displays error message 2
Intermittent continuity 2
Malfunction 2
Malposition of device 2
Trocar failure 2
Break 2
No Information 2
Device, removal of (non-implant) 2
Poor quality image 2
Device remains implanted 1
Air leak 1
Probe failure 1
Failure to power-up 1
No device output 1
Material perforation 1
Calibration issue 1
Reuse 1
Device or device fragments location unknown 1
Positioning Issue 1
Failure to disconnect 1
Replace 1
Component missing 1
Suction issue 1
Unexpected therapeutic results 1
Loss of Data 1
Device contamination with blood or blood product 1
Incompatibility problem 1
Spring loading mechanism problem 1
Patient-device incompatibility 1
Foreign material 1
Total Device Problems 2510

Recalls
  2007 2008 2009 2010 2011 2012 2013 2014 2015 2016 2017
Class I 0 0 0 0 0 0 0 0 0 0 0
Class II 0 1 0 0 0 0 0 0 0 1 0
Class III 0 0 0 0 0 0 0 0 0 0 0

Recalls
Manufacturer Recall Class Date Posted
1 Covidien LLC II May-06-2016
2 Medtronic Neuromodulation II May-07-2008

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