TPLC - Total Product Life Cycle

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Device	focused ultrasound system for non-thermal, mechanical tissue ablation
Definition	This device uses focused ultrasound to mechanically ablate soft tissue. The device is not intended to thermally ablate tissue.
Product Code	QGM
Regulation Number	878.4405
Device Class	2

Device Problems	MDRs with this Device Problem	Events in those MDRs
Adverse Event Without Identified Device or Use Problem	50	50

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
Renal Impairment	16	16
Hemorrhage/Bleeding	9	9
Low Blood Pressure/ Hypotension	7	7
Pseudoaneurysm	7	7
Abdominal Pain	4	4
Anemia	4	4
Thrombosis/Thrombus	4	4
Renal Failure	4	4
Pain	4	4
Intra-Abdominal Hemorrhage	3	3
Gastrointestinal Hemorrhage	3	3
Fever	3	3
Urinary Retention	3	3
High Blood Pressure/ Hypertension	2	2
Liver Damage/Dysfunction	2	2
Nausea	2	2
Ascites	2	2
Sepsis	2	2
Hematuria	2	2
Hemoptysis	2	2
Ruptured Aneurysm	2	2
Cardiac Arrest	2	2
Vomiting	2	2
Aspiration Pneumonitis	1	1
Ambulation Difficulties	1	1
Bruise/Contusion	1	1
Full thickness (Third Degree) Burn	1	1
Hypoxia	1	1
Thrombocytopenia	1	1
Unspecified Respiratory Problem	1	1
Myocardial Infarction	1	1
Partial thickness (Second Degree) Burn	1	1
Tachycardia	1	1
Swelling/ Edema	1	1
Abscess	1	1
Pneumonia	1	1
Pleural Effusion	1	1
Erythema	1	1
Insufficient Information	1	1
Vertigo	1	1
Discomfort	1	1
Uremia	1	1
Chills	1	1
Angina	1	1
Confusion/ Disorientation	1	1
Respiratory Acidosis	1	1
Head Injury	1	1
Aspiration/Inhalation	1	1
Abdominal Distention	1	1
Necrosis	1	1