TPLC - Total Product Life Cycle

• 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	1
BAYLIS MEDICAL COMPANY INC.
	SUBSTANTIALLY EQUIVALENT	1
NEUROONE MEDICAL TECHNOLOGIES CORP.
	SUBSTANTIALLY EQUIVALENT	1
RF INNOVATIONS, INC
	SUBSTANTIALLY EQUIVALENT	1

MDR Year	MDR Reports	MDR Events
2019	195	195
2020	138	138
2021	154	154
2022	84	84
2023	54	54
2024	11	11

Device Problems	MDRs with this Device Problem	Events in those MDRs
Insufficient Heating	112	112
Adverse Event Without Identified Device or Use Problem	80	80
Output Problem	71	71
Communication or Transmission Problem	55	55
Thermal Decomposition of Device	40	40
Temperature Problem	39	39
Unexpected Shutdown	30	30
Failure to Power Up	28	28
Smoking	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
High impedance	13	13
Insufficient Information	13	13
Unintended Electrical Shock	9	9
Mechanical Problem	9	9
Fracture	8	8
No Display/Image	8	8
Power Problem	8	8
Connection Problem	7	7
Grounding Malfunction	6	6
Energy Output Problem	6	6
Material Separation	6	6
Display or Visual Feedback Problem	5	5
Impedance Problem	5	5
No Apparent Adverse Event	3	3
Application Program Freezes, Becomes Nonfunctional	3	3
Low impedance	3	3
Defective Device	3	3
Failure to Disconnect	2	2
Loss of Threshold	2	2
Use of Device Problem	2	2
Improper or Incorrect Procedure or Method	2	2
Electrical /Electronic Property Problem	2	2
Disconnection	2	2
Intermittent Communication Failure	2	2
Separation Problem	2	2
No Tactile Prompts/Feedback	2	2
Appropriate Term/Code Not Available	2	2
Environmental Compatibility Problem	2	2
Detachment of Device or Device Component	1	1
Protective Measures Problem	1	1
Intermittent Loss of Power	1	1
Therapeutic or Diagnostic Output Failure	1	1
Excessive Heating	1	1
Audible Prompt/Feedback Problem	1	1
Tactile Prompts/Feedback	1	1
Fail-Safe Did Not Operate	1	1
Erratic or Intermittent Display	1	1
Fire	1	1
Fluid/Blood Leak	1	1
Break	1	1
Loose or Intermittent Connection	1	1
Device Remains Activated	1	1
Failure to Analyze Signal	1	1
Failure to Sense	1	1
Defibrillation/Stimulation Problem	1	1
Inappropriate/Inadequate Shock/Stimulation	1	1
Structural Problem	1	1
Sparking	1	1
Patient-Device Incompatibility	1	1
Application Program Problem	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	275	275
No Consequences Or Impact To Patient	239	239
Partial thickness (Second Degree) Burn	44	44
Burn(s)	30	30
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	6	6
Electric Shock	5	5
Insufficient Information	5	5
Inadequate Pain Relief	4	4
Muscle Weakness	3	3
Burning Sensation	3	3
No Information	3	3
Spinal Cord Injury	2	2
Burn, Thermal	1	1
Foreign Body In Patient	1	1
Shock from Patient Lead(s)	1	1
Not Applicable	1	1
No Code Available	1	1
Constipation	1	1
Speech Disorder	1	1
Paresthesia	1	1
Cramp(s) /Muscle Spasm(s)	1	1
Osteomyelitis	1	1
Bacterial Infection	1	1
Device Overstimulation of Tissue	1	1
Numbness	1	1
Discomfort	1	1
Peeling	1	1
Staphylococcus Aureus	1	1
Shock	1	1
Urinary Retention	1	1
Cellulitis	1	1
Erythema	1	1
Fever	1	1
Inflammation	1	1
Irritation	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