TPLC - Total Product Life Cycle

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Device	generator, lesion, radiofrequency
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
BAYLIS MEDICAL COMPANY INC.
	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	113	113
Adverse Event Without Identified Device or Use Problem	84	84
Output Problem	74	74
Communication or Transmission Problem	55	55
Temperature Problem	41	41
Thermal Decomposition of Device	40	40
Unexpected Shutdown	30	30
Smoking	28	28
Failure to Power Up	28	28
Material Deformation	24	24
Failure to Deliver Energy	19	19
Noise, Audible	16	16
Device Emits Odor	15	15
Overheating of Device	14	14
Fracture	14	14
High impedance	13	13
Insufficient Information	13	13
Mechanical Problem	9	9
Unintended Electrical Shock	9	9
Connection Problem	8	8
No Display/Image	8	8
Power Problem	8	8
Grounding Malfunction	6	6
Energy Output Problem	6	6
Material Separation	6	6
Display or Visual Feedback Problem	5	5
Impedance Problem	5	5
Defective Device	4	4
Use of Device Problem	3	3
No Apparent Adverse Event	3	3
Low impedance	3	3
Application Program Freezes, Becomes Nonfunctional	3	3
Environmental Compatibility Problem	2	2
Device Handling Problem	2	2
Loss of Threshold	2	2
Appropriate Term/Code Not Available	2	2
Separation Problem	2	2
No Tactile Prompts/Feedback	2	2
Electrical /Electronic Property Problem	2	2
Improper or Incorrect Procedure or Method	2	2
Failure to Disconnect	2	2
Intermittent Communication Failure	2	2
Disconnection	2	2
Structural Problem	1	1
Therapeutic or Diagnostic Output Failure	1	1
Audible Prompt/Feedback Problem	1	1
Failure to Sense	1	1
Fail-Safe Did Not Operate	1	1
Defibrillation/Stimulation Problem	1	1
Inappropriate/Inadequate Shock/Stimulation	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	290	290
No Consequences Or Impact To Patient	239	239
Partial thickness (Second Degree) Burn	47	47
Burn(s)	32	32
No Patient Involvement	26	26
Pain	12	12
Full thickness (Third Degree) Burn	8	8
No Known Impact Or Consequence To Patient	8	8
Superficial (First Degree) Burn	7	7
Electric Shock	5	5
Insufficient Information	5	5
Muscle Weakness	4	4
Inadequate Pain Relief	4	4
No Information	3	3
Burning Sensation	3	3
Speech Disorder	2	2
Spinal Cord Injury	2	2
Erythema	2	2
Constipation	1	1
Paraplegia	1	1
Bacterial Infection	1	1
Shock	1	1
Peeling	1	1
Numbness	1	1
Discomfort	1	1
Urinary Retention	1	1
Osteomyelitis	1	1
Foreign Body In Patient	1	1
Irritation	1	1
Fever	1	1
Paresthesia	1	1
Staphylococcus Aureus	1	1
Device Overstimulation of Tissue	1	1
Cellulitis	1	1
Blister	1	1
Cramp(s) /Muscle Spasm(s)	1	1
Burn, Thermal	1	1
Inflammation	1	1
No Code Available	1	1
Not Applicable	1	1
Shock from Patient Lead(s)	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	Abbott Medical	II	Dec-10-2019
4	Avanos Medical, Inc.	II	Sep-21-2023