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
EPIMED INTERNATIONAL
	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	26	26

Device Problems	MDRs with this Device Problem	Events in those MDRs
Insufficient Heating	113	113
Adverse Event Without Identified Device or Use Problem	83	83
Output Problem	71	71
Communication or Transmission Problem	55	55
Temperature Problem	40	40
Thermal Decomposition of Device	40	40
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
Fracture	12	12
Mechanical Problem	9	9
Unintended Electrical Shock	9	9
Connection Problem	8	8
Power Problem	8	8
No Display/Image	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
Low impedance	3	3
Use of Device Problem	3	3
No Apparent Adverse Event	3	3
Application Program Freezes, Becomes Nonfunctional	3	3
Intermittent Communication Failure	2	2
Separation Problem	2	2
No Tactile Prompts/Feedback	2	2
Appropriate Term/Code Not Available	2	2
Device Handling Problem	2	2
Environmental Compatibility Problem	2	2
Improper or Incorrect Procedure or Method	2	2
Loss of Threshold	2	2
Failure to Disconnect	2	2
Electrical /Electronic Property Problem	2	2
Disconnection	2	2
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
Structural Problem	1	1
Sparking	1	1
Patient-Device Incompatibility	1	1
Application Program Problem	1	1
Defibrillation/Stimulation Problem	1	1
Inappropriate/Inadequate Shock/Stimulation	1	1
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

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	285	285
No Consequences Or Impact To Patient	239	239
Partial thickness (Second Degree) Burn	45	45
Burn(s)	32	32
No Patient Involvement	26	26
Pain	12	12
No Known Impact Or Consequence To Patient	8	8
Full thickness (Third Degree) Burn	8	8
Superficial (First Degree) Burn	7	7
Electric Shock	5	5
Insufficient Information	5	5
Inadequate Pain Relief	4	4
Muscle Weakness	4	4
Burning Sensation	3	3
No Information	3	3
Erythema	2	2
Spinal Cord Injury	2	2
Speech Disorder	2	2
Paresthesia	1	1
Cramp(s) /Muscle Spasm(s)	1	1
Osteomyelitis	1	1
Blister	1	1
Shock from Patient Lead(s)	1	1
Not Applicable	1	1
Burn, Thermal	1	1
Numbness	1	1
Foreign Body In Patient	1	1
Fever	1	1
Inflammation	1	1
Irritation	1	1
Device Overstimulation of Tissue	1	1
Cellulitis	1	1
Bacterial Infection	1	1
Discomfort	1	1
Peeling	1	1
Staphylococcus Aureus	1	1
Shock	1	1
Urinary Retention	1	1
No Code Available	1	1
Constipation	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