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	1
AVANOS MEDICAL, INC.
	SUBSTANTIALLY EQUIVALENT	1
BOSTON SCIENTIFIC NEUROMODULATION CORPORATION
	SUBSTANTIALLY EQUIVALENT	1
EPIMED INTERNATIONAL
	SUBSTANTIALLY EQUIVALENT	1
NEUROONE MEDICAL TECHNOLOGIES CORP.
	SUBSTANTIALLY EQUIVALENT	1
1. K231675 OneRF Ablation System
RF INNOVATIONS, INC.
	SUBSTANTIALLY EQUIVALENT	1

Device Problems	MDRs with this Device Problem	Events in those MDRs
Insufficient Heating	81	81
Fracture	75	75
Output Problem	59	59
Adverse Event Without Identified Device or Use Problem	47	51
Thermal Decomposition of Device	26	26
Communication or Transmission Problem	22	22
Smoking	17	17
Temperature Problem	13	13
Connection Problem	12	12
Unexpected Shutdown	11	11
Overheating of Device	9	9
High impedance	9	9
Failure to Deliver Energy	8	8
Mechanical Problem	7	7
Grounding Malfunction	7	7
Degraded	6	6
Failure to Power Up	6	6
Impedance Problem	6	6
Device Emits Odor	6	6
Power Problem	5	5
No Display/Image	5	5
Unintended Electrical Shock	5	5
Defective Device	4	4
Energy Output Problem	4	4
Insufficient Information	4	4
Use of Device Problem	3	3
Structural Problem	3	3
Patient Device Interaction Problem	3	3
Noise, Audible	3	3
Defibrillation/Stimulation Problem	2	2
Display or Visual Feedback Problem	2	2
Disconnection	2	2
Loss of or Failure to Bond	2	2
No Apparent Adverse Event	2	2
Device Handling Problem	2	2
Loose or Intermittent Connection	1	1
Failure of Device to Self-Test	1	1
Intermittent Loss of Power	1	1
Difficult to Remove	1	1
Computer Operating System Problem	1	1
Break	1	1
Protective Measures Problem	1	1
Application Program Problem	1	1
Patient-Device Incompatibility	1	4
Erratic or Intermittent Display	1	1
Sparking	1	1
Fail-Safe Did Not Operate	1	2
Application Program Freezes, Becomes Nonfunctional	1	1
Fire	1	1
Output below Specifications	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	370	370
Partial thickness (Second Degree) Burn	25	25
Pain	16	16
Burn(s)	10	11
Full thickness (Third Degree) Burn	9	9
Superficial (First Degree) Burn	7	14
Electric Shock	5	5
Insufficient Information	5	5
Muscle Weakness	4	4
Inadequate Pain Relief	4	4
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	3	3
Foreign Body In Patient	3	3
Speech Disorder	2	2
Burning Sensation	2	2
Erythema	2	2
Spinal Cord Injury	2	2
High Blood Pressure/ Hypertension	1	1
Arrhythmia	1	1
Shock from Patient Lead(s)	1	1
Fatigue	1	1
No Information	1	1
Cramp(s) /Muscle Spasm(s)	1	1
Blister	1	1
Paresthesia	1	1
Cellulitis	1	1
Unspecified Nervous System Problem	1	1
Fever	1	1
Osteomyelitis	1	1
Numbness	1	1
Urinary Retention	1	1
Chest Pain	1	1
Nerve Damage	1	1
Peeling	1	1
Fall	1	1
No Consequences Or Impact To Patient	1	1
Constipation	1	1
Bacterial Infection	1	1
Paraplegia	1	1
Ambulation Difficulties	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