TPLC - Total Product Life Cycle

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Device	focused ultrasound for tissue heat or mechanical cellular disruption
Regulation Description	Focused ultrasound stimulator system for aesthetic use.
Definition	A device using focused ultrasound to produce localized, mechanical motion within tissues and cells for the purpose of producing either localized heating for tissue coagulation or for mechanical cellular membrane disruption intended for non-invasive aesthetic use.
Product Code	OHV
Regulation Number	878.4590
Device Class	2

Device Problems	MDRs with this Device Problem	Events in those MDRs
Adverse Event Without Identified Device or Use Problem	27	27
Improper or Incorrect Procedure or Method	8	8
Insufficient Information	6	6
Sparking	5	5
Patient Device Interaction Problem	4	4
Use of Device Problem	3	3
Break	2	2
Fracture	2	2
Patient-Device Incompatibility	2	3
Noise, Audible	2	2
Unintended Electrical Shock	2	2
Failure to Power Up	2	2
Off-Label Use	2	2
No Display/Image	1	1
Dent in Material	1	1
Expiration Date Error	1	9
Defective Device	1	1
Computer Operating System Problem	1	1
Defibrillation/Stimulation Problem	1	1
Inappropriate/Inadequate Shock/Stimulation	1	1
Smoking	1	1
Output Problem	1	9
Scratched Material	1	1
Physical Resistance/Sticking	1	1
Failure to Clean Adequately	1	1
Inaccurate Information	1	9
Key or Button Unresponsive/not Working	1	1
Lack of Effect	1	1
Image Display Error/Artifact	1	1
Energy Output Problem	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
Pain	14	15
Scar Tissue	13	13
Deformity/ Disfigurement	11	11
Burn(s)	11	11
No Clinical Signs, Symptoms or Conditions	8	16
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	7	7
Insufficient Information	6	6
Nerve Damage	6	6
Skin Discoloration	6	6
Erythema	5	5
Superficial (First Degree) Burn	4	4
Swelling/ Edema	4	4
Wheal(s)	4	4
Headache	4	4
Bruise/Contusion	3	3
Neuropathy	3	3
Visual Impairment	3	4
Emotional Changes	3	3
Unspecified Tissue Injury	3	3
Dry Eye(s)	3	3
Burning Sensation	3	3
Nodule	3	4
Partial thickness (Second Degree) Burn	3	3
Paresis	2	2
Dyspnea	2	2
Vitreous Floaters	2	2
Blurred Vision	2	2
Muscle Weakness	2	2
Electric Shock	2	2
Full thickness (Third Degree) Burn	2	2
Tissue Breakdown	2	2
Urticaria	2	2
Skin Tears	1	1
Loss of Vision	1	1
Hemorrhage/Bleeding	1	1
Undesired Nerve Stimulation	1	1
Unspecified Vascular Problem	1	1
Subcutaneous Nodule	1	1
Sensitivity of Teeth	1	1
Pyogenic Infection	1	1
Nervous System Injury	1	1
Distress	1	1
Vomiting	1	1
Vertigo	1	1
Unspecified Eye / Vision Problem	1	1
Salivary Gland Problem	1	1
Rash	1	1
Unspecified Mental, Emotional or Behavioural Problem	1	1
Visual Disturbances	1	1
Flashers	1	1

Recalls
Manufacturer		Recall Class	Date Posted
1	RoyalVibe Health Ltd.	II	Oct-06-2023