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
Thrombosis/Thrombus	4	4
Anemia	4	4
Abdominal Pain	4	4
Pain	4	4
Renal Failure	4	4
Urinary Retention	3	3
Fever	3	3
Gastrointestinal Hemorrhage	3	3
Intra-Abdominal Hemorrhage	3	3
Ruptured Aneurysm	2	2
Hemoptysis	2	2
High Blood Pressure/ Hypertension	2	2
Cardiac Arrest	2	2
Hematuria	2	2
Ascites	2	2
Vomiting	2	2
Sepsis	2	2
Liver Damage/Dysfunction	2	2
Nausea	2	2
Necrosis	1	1
Myocardial Infarction	1	1
Tachycardia	1	1
Pleural Effusion	1	1
Pneumonia	1	1
Uremia	1	1
Chills	1	1
Discomfort	1	1
Respiratory Acidosis	1	1
Ambulation Difficulties	1	1
Confusion/ Disorientation	1	1
Abdominal Distention	1	1
Vertigo	1	1
Erythema	1	1
Fatigue	1	1
Abscess	1	1
Adult Respiratory Distress Syndrome	1	1
Angina	1	1
Aspiration/Inhalation	1	1
Bruise/Contusion	1	1
Hypoxia	1	1
Head Injury	1	1
Hyperbilirubinemia	1	1
Swelling/ Edema	1	1
Insufficient Information	1	1
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	1	1
No Clinical Signs, Symptoms or Conditions	1	1