TPLC - Total Product Life Cycle

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Device	generator, lesion, radiofrequency
Regulation Description	Radiofrequency lesion generator.
Product Code	GXD
Regulation Number	882.4400
Device Class	2

Premarket Reviews
Manufacturer	Decision
ABBOTT MEDICAL
	SUBSTANTIALLY EQUIVALENT	2
AVANOS MEDICAL, INC.
	SUBSTANTIALLY EQUIVALENT	2
BOSTON SCIENTIFIC NEUROMODULATION CORPORATION
	SUBSTANTIALLY EQUIVALENT	1
EPIMED INTERNATIONAL
	SUBSTANTIALLY EQUIVALENT	1
NEUROONE MEDICAL TECHNOLOGIES CORP.
	SUBSTANTIALLY EQUIVALENT	1
RF INNOVATIONS, INC
	SUBSTANTIALLY EQUIVALENT	1

Device Problems	MDRs with this Device Problem	Events in those MDRs
Insufficient Heating	103	103
Fracture	73	73
Output Problem	67	67
Adverse Event Without Identified Device or Use Problem	59	63
Thermal Decomposition of Device	39	39
Communication or Transmission Problem	32	32
Temperature Problem	28	28
Smoking	24	24
Unexpected Shutdown	22	22
Failure to Deliver Energy	18	18
High impedance	15	15
Device Emits Odor	15	15
Overheating of Device	13	13
Connection Problem	13	13
Failure to Power Up	13	13
Insufficient Information	12	12
Noise, Audible	11	11
Mechanical Problem	8	8
Unintended Electrical Shock	7	7
No Display/Image	6	6
Grounding Malfunction	6	6
Degraded	6	6
Power Problem	5	5
Impedance Problem	5	5
Defective Device	4	4
Display or Visual Feedback Problem	4	4
Energy Output Problem	4	4
Patient Device Interaction Problem	3	3
Structural Problem	3	3
Disconnection	2	2
Electrical /Electronic Property Problem	2	2
Sparking	2	2
No Tactile Prompts/Feedback	2	2
Appropriate Term/Code Not Available	2	2
Loss of Threshold	2	2
No Apparent Adverse Event	2	2
Defibrillation/Stimulation Problem	2	2
Device Handling Problem	2	2
Use of Device Problem	2	2
Inappropriate/Inadequate Shock/Stimulation	1	1
Detachment of Device or Device Component	1	1
Material Separation	1	1
Erratic or Intermittent Display	1	1
Patient-Device Incompatibility	1	4
Low impedance	1	1
Application Program Problem	1	1
Protective Measures Problem	1	1
Computer Operating System Problem	1	1
Excessive Heating	1	1
Application Program Freezes, Becomes Nonfunctional	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	384	384
No Consequences Or Impact To Patient	108	108
Partial thickness (Second Degree) Burn	35	35
Burn(s)	17	18
Pain	16	16
Full thickness (Third Degree) Burn	9	9
No Known Impact Or Consequence To Patient	8	8
Superficial (First Degree) Burn	7	14
Insufficient Information	7	7
Electric Shock	5	5
Inadequate Pain Relief	4	4
Muscle Weakness	4	4
No Patient Involvement	4	4
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	3	3
No Information	3	3
Foreign Body In Patient	3	3
Spinal Cord Injury	2	2
Erythema	2	2
Burning Sensation	2	2
Speech Disorder	2	2
Unspecified Nervous System Problem	1	1
Paresthesia	1	1
Fever	1	1
Cellulitis	1	1
Blister	1	1
Osteomyelitis	1	1
Chest Pain	1	1
Cramp(s) /Muscle Spasm(s)	1	1
Nerve Damage	1	1
Urinary Retention	1	1
Numbness	1	1
Burn, Thermal	1	1
No Code Available	1	1
Fall	1	1
Not Applicable	1	1
Peeling	1	1
Shock	1	1
Shock from Patient Lead(s)	1	1
Bacterial Infection	1	1
Fatigue	1	1
Paraplegia	1	1
Constipation	1	1
Arrhythmia	1	1
High Blood Pressure/ Hypertension	1	1
Ambulation Difficulties	1	1

Recalls
Manufacturer		Recall Class	Date Posted
1	Abbott	II	Nov-02-2023
2	Abbott Laboratories Inc. (St Jude Medical)	II	May-10-2021
3	Avanos Medical, Inc.	II	Sep-21-2023