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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 384
Handpiece break 123
Unknown (for use when the device problem is not known) 68
Failure to advance 65
Difficult to deploy 43
Communication or transmission issue 31
Device operates differently than expected 30
No Known Device Problem 30
Failure to transmit record 14
Detachment of device or device component 11
Detachment of device component 8
Data Issue 7
Invalid sensing 6
Entrapment of device or device component 6
Incorrect or inadequate result 6
Device displays error message 5
High pH 4
Device Issue 4
Connection issue 4
Failure to separate 4
Premature deployment 4
Loss of or failure to bond 4
Calibration error 3
Explanted 3
No display or display failure 3
Difficult to position 3
Difficult to remove 3
Improper or incorrect procedure or method 3
Output issue 3
Implant, removal of 3
Trocar failure 2
Malfunction 2
High Readings 2
Device, removal of (non-implant) 2
Malposition of device 2
Power source issue 2
No Information 2
Calibration issue 2
Deployment issue 2
Device, or device fragments remain in patient 2
Poor quality image 2
Intermittent continuity 2
Break 2
Bent 2
Air leak 1
No device output 1
False device output 1
Foreign material 1
Device remains implanted 1
Failure to power-up 1
Probe failure 1
Suction issue 1
Replace 1
Reuse 1
Spring loading mechanism problem 1
Unexpected therapeutic results 1
Incompatibility problem 1
Device or device fragments location unknown 1
Loss of Data 1
Positioning Issue 1
Patient-device incompatibility 1
Failure to disconnect 1
Component missing 1
Device contamination with blood or blood product 1
Material perforation 1
Total Device Problems 2561

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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