TPLC - Total Product Life Cycle

show TPLC since

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	102	102
Output Problem	64	64
Adverse Event Without Identified Device or Use Problem	54	54
Fracture	48	48
Thermal Decomposition of Device	39	39
Communication or Transmission Problem	31	31
Temperature Problem	24	24
Smoking	24	24
Unexpected Shutdown	21	21
Failure to Deliver Energy	18	18
Device Emits Odor	15	15
High impedance	13	13
Failure to Power Up	13	13
Overheating of Device	12	12
Noise, Audible	11	11
Insufficient Information	11	11
Connection Problem	9	9
Mechanical Problem	8	8
Unintended Electrical Shock	7	7
No Display/Image	6	6
Grounding Malfunction	6	6
Impedance Problem	5	5
Power Problem	5	5
Defective Device	4	4
Display or Visual Feedback Problem	4	4
Energy Output Problem	3	3
Structural Problem	3	3
Disconnection	2	2
Degraded	2	2
Use of Device Problem	2	2
Device Handling Problem	2	2
Electrical /Electronic Property Problem	2	2
Defibrillation/Stimulation Problem	2	2
No Apparent Adverse Event	2	2
Loss of Threshold	2	2
No Tactile Prompts/Feedback	2	2
Appropriate Term/Code Not Available	2	2
Device Remains Activated	1	1
Fluid/Blood Leak	1	1
Intermittent Loss of Power	1	1
Failure to Disconnect	1	1
Improper or Incorrect Procedure or Method	1	1
Loose or Intermittent Connection	1	1
Failure to Analyze Signal	1	1
Sparking	1	1
Failure of Device to Self-Test	1	1
Break	1	1
Application Program Freezes, Becomes Nonfunctional	1	1
Excessive Heating	1	1
Protective Measures Problem	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	342	342
No Consequences Or Impact To Patient	108	108
Partial thickness (Second Degree) Burn	32	32
Burn(s)	16	16
Pain	12	12
No Known Impact Or Consequence To Patient	8	8
Superficial (First Degree) Burn	7	7
Full thickness (Third Degree) Burn	7	7
Electric Shock	5	5
Insufficient Information	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
Shock from Patient Lead(s)	1	1
Not Applicable	1	1
No Code Available	1	1
Bone Fracture(s)	1	1
Burn, Thermal	1	1
Cramp(s) /Muscle Spasm(s)	1	1
Blister	1	1
Cellulitis	1	1
Movement Disorder	1	1
Paresthesia	1	1
Fever	1	1
Osteomyelitis	1	1
Urinary Retention	1	1
Numbness	1	1
Peeling	1	1
Shock	1	1
Bacterial Infection	1	1
Paraplegia	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	Avanos Medical, Inc.	II	Sep-21-2023