TPLC - Total Product Life Cycle

Device	catheter, electrode recording, or probe, electrode recording
Regulation Description	Electrode recording catheter or electrode recording probe.
Product Code	DRF
Regulation Number	870.1220
Device Class	2

Device Problems
No Known Device Problem	100
Difficult to remove	21
Temperature issue	9
Not Applicable	7
No Information	7
Mechanical issue	7
Material separation	7
Kinked	6
Break	5
Wire(s), breakage of	5
Leak	4
Detachment of device component	4
Out-of-box failure	3
Device operates differently than expected	3
Charred	3
Crack	3
Use of Device Issue	3
Defective item	3
Difficult to position	2
Output above specifications	2
Entrapment of device or device component	2
Device operational issue	2
Material Protrusion	1
Air leak	1
Physical resistance	1
Patient-device incompatibility	1
Communication or transmission issue	1
Electrode(s), failure of	1
Knotted	1
Normal	1
Failure to read input signal	1
Tip breakage	1
Device inoperable	1
Tube(s), defective	1
Device-device incompatibility	1
Foreign material present in device	1
Material deformation	1
Output below specifications	1
Unable to obtain readings	1
Device remains activated	1
Device damaged prior to use	1
Device displays error message	1
Device alarm system issue	1
Erratic display	1
Electrical issue	1
Material perforation	1
Split	1
Degraded	1
No code available	1
Detachment of device or device component	1
Dislodged or dislocated	1
Output issue	1
Total Device Problems	238