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
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
Output Problem	64	64
Fracture	61	61
Adverse Event Without Identified Device or Use Problem	55	55
Thermal Decomposition of Device	39	39
Communication or Transmission Problem	31	31
Temperature Problem	27	27
Smoking	24	24
Unexpected Shutdown	21	21
Failure to Deliver Energy	18	18
Device Emits Odor	15	15
High impedance	14	14
Failure to Power Up	13	13
Overheating of Device	12	12
Connection Problem	12	12
Noise, Audible	11	11
Insufficient Information	11	11
Mechanical Problem	8	8
Unintended Electrical Shock	7	7
No Display/Image	6	6
Grounding Malfunction	6	6
Power Problem	5	5
Impedance Problem	5	5
Display or Visual Feedback Problem	4	4
Defective Device	4	4
Energy Output Problem	3	3
Structural Problem	3	3
Electrical /Electronic Property Problem	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
Degraded	2	2
Sparking	2	2
Disconnection	2	2
Material Separation	1	1
Inappropriate/Inadequate Shock/Stimulation	1	1
Detachment of Device or Device Component	1	1
Lack of Effect	1	1
Erratic or Intermittent Display	1	1
Audible Prompt/Feedback Problem	1	1
Low impedance	1	1
Protective Measures Problem	1	1
Difficult to Remove	1	1
Excessive Heating	1	1
Application Program Freezes, Becomes Nonfunctional	1	1
Failure to Sense	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	363	363
No Consequences Or Impact To Patient	108	108
Partial thickness (Second Degree) Burn	32	32
Burn(s)	16	16
Pain	13	13
No Known Impact Or Consequence To Patient	8	8
Superficial (First Degree) Burn	7	7
Full thickness (Third Degree) Burn	7	7
Insufficient Information	6	6
Electric Shock	5	5
Muscle Weakness	4	4
No Patient Involvement	4	4
Inadequate Pain Relief	4	4
No Information	3	3
Foreign Body In Patient	3	3
Speech Disorder	2	2
Burning Sensation	2	2
Erythema	2	2
Spinal Cord Injury	2	2
Not Applicable	1	1
No Code Available	1	1
Shock from Patient Lead(s)	1	1
Bone Fracture(s)	1	1
Burn, Thermal	1	1
Cramp(s) /Muscle Spasm(s)	1	1
Blister	1	1
Paresthesia	1	1
Cellulitis	1	1
Movement Disorder	1	1
Fever	1	1
Osteomyelitis	1	1
Numbness	1	1
Urinary Retention	1	1
Peeling	1	1
Shock	1	1
Constipation	1	1
Bacterial Infection	1	1
Paraplegia	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