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
RF INNOVATIONS, INC
	SUBSTANTIALLY EQUIVALENT	1

MDR Year	MDR Reports	MDR Events
2018	156	156
2019	197	197
2020	138	138
2021	154	154
2022	84	84
2023	25	25

Device Problems	MDRs with this Device Problem	Events in those MDRs
Adverse Event Without Identified Device or Use Problem	110	110
Insufficient Heating	106	106
Temperature Problem	79	79
Output Problem	66	66
Communication or Transmission Problem	64	64
Failure to Power Up	44	44
Thermal Decomposition of Device	39	39
Unexpected Shutdown	33	33
Smoking	32	32
Failure to Deliver Energy	24	24
Material Deformation	24	24
Noise, Audible	17	17
Overheating of Device	15	15
Device Emits Odor	15	15
High impedance	14	14
Impedance Problem	12	12
Insufficient Information	11	11
Device Operates Differently Than Expected	10	10
Unintended Electrical Shock	10	10
No Display/Image	9	9
Power Problem	8	8
Display or Visual Feedback Problem	8	8
Mechanical Problem	7	7
Fracture	6	6
Device Displays Incorrect Message	6	6
Connection Problem	6	6
Material Separation	5	5
Intermittent Communication Failure	4	4
Energy Output Problem	4	4
Low impedance	3	3
Application Program Freezes, Becomes Nonfunctional	3	3
Use of Device Problem	3	3
Defective Device	3	3
Break	2	2
No Tactile Prompts/Feedback	2	2
Separation Problem	2	2
Loose or Intermittent Connection	2	2
Disconnection	2	2
Erratic or Intermittent Display	2	2
Failure to Disconnect	2	2
Environmental Compatibility Problem	2	2
Loss of Threshold	2	2
Therapeutic or Diagnostic Output Failure	2	2
Appropriate Term/Code Not Available	2	2
Electrical /Electronic Property Problem	2	2
Device Remains Activated	2	2
Improper or Incorrect Procedure or Method	2	2
Inappropriate/Inadequate Shock/Stimulation	1	1
Device Stops Intermittently	1	1
Fail-Safe Did Not Operate	1	1
Sparking	1	1
Patient-Device Incompatibility	1	1
Energy Output To Patient Tissue Incorrect	1	1
Fire	1	1
Device Operational Issue	1	1
No Apparent Adverse Event	1	1
Structural Problem	1	1
Failure of Device to Self-Test	1	1
Excessive Heating	1	1
Protective Measures Problem	1	1
Intermittent Loss of Power	1	1
Electromagnetic Interference	1	1
Application Program Problem	1	1
Loss of Power	1	1
Grounding Malfunction	1	1
Failure to Analyze Signal	1	1
Audible Prompt/Feedback Problem	1	1
Tactile Prompts/Feedback	1	1
Detachment of Device or Device Component	1	1
No Device Output	1	1
Fluid/Blood Leak	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Consequences Or Impact To Patient	351	351
No Clinical Signs, Symptoms or Conditions	246	246
Burn(s)	54	54
Partial thickness (Second Degree) Burn	51	51
No Patient Involvement	26	26
No Known Impact Or Consequence To Patient	15	15
Pain	11	11
Full thickness (Third Degree) Burn	9	9
Superficial (First Degree) Burn	6	6
Insufficient Information	4	4
Inadequate Pain Relief	4	4
No Information	4	4
Burn, Thermal	3	3
Electric Shock	2	2
Muscle Weakness	2	2
Burning Sensation	2	2
Spinal Cord Injury	2	2
Foreign Body In Patient	2	2
Not Applicable	1	1
No Code Available	1	1
Constipation	1	1
Cellulitis	1	1
Shock	1	1
Urinary Retention	1	1
Osteomyelitis	1	1
Inflammation	1	1
Device Overstimulation of Tissue	1	1
Peeling	1	1
Paresthesia	1	1
Cramp(s) /Muscle Spasm(s)	1	1
Bacterial Infection	1	1
Irritation	1	1
Discomfort	1	1
Erythema	1	1
Fever	1	1
Staphylococcus Aureus	1	1
Numbness	1	1

Recalls
Manufacturer		Recall Class	Date Posted
1	Abbott Laboratories Inc. (St Jude Medical)	II	May-10-2021
2	Abbott Medical	II	Dec-10-2019