TPLC - Total Product Life Cycle

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Premarket Reviews
Manufacturer	Decision
BOSTON SCIENTIFIC CORPORATION
	SUBSTANTIALLY EQUIVALENT	1
HOLOGIC, INC.
	SUBSTANTIALLY EQUIVALENT	1
KARL STORZ SE & CO. KG
	SUBSTANTIALLY EQUIVALENT	1
THERMEDX, LLC
	SUBSTANTIALLY EQUIVALENT	1

Device Problems	MDRs with this Device Problem	Events in those MDRs
Material Fragmentation	131	131
Adverse Event Without Identified Device or Use Problem	23	23
Insufficient Device Problem Information	22	22
Use of Device Problem	11	11
Pressure Problem	10	10
Output Problem	7	7
Device Contaminated During Manufacture or Shipping	6	6
Infusion or Flow Problem	5	5
Power Problem	3	3
Increase in Pressure	3	3
Improper Flow or Infusion	3	3
No Apparent Adverse Event	3	3
Material Rupture	3	3
Material Separation	3	3
Leak/Splash	2	2
Volume Accuracy Problem	2	2
Application Program Problem	2	2
Failure to Obtain Sample	2	2
Pumping Stopped	2	2
Incorrect, Inadequate or Imprecise Result or Readings	2	2
High Readings	2	2
Air/Gas in Device	2	2
Device Damaged Prior to Receipt by User	2	2
Incorrect Measurement	2	2
Fluid/Blood Leak	1	1
Improper or Incorrect Procedure or Method	1	1
Loss of Power	1	1
Failure to Analyze Signal	1	1
Suction Problem	1	1
Nonstandard Device	1	1
Fracture	1	1
Detachment of Device or Device Component	1	1
Low Readings	1	1
Packaging Problem	1	1
Optical Problem	1	1
Calibration Problem	1	1
Date/Time-Related Software Problem	1	1
Lack of Effect	1	1
Problem with Software Installation	1	1
Moisture Damage	1	1
Contamination	1	1
Material Puncture/Hole	1	1
Pumping Problem	1	1
Off-Label Use	1	1
False Negative Result	1	1
Break	1	1
Separation Problem	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	269	269
Insufficient Information	28	28
Hypervolemia	11	11
Pulmonary Edema	5	5
Air Embolism	4	4
Perforation	4	4
Unspecified Heart Problem	4	4
Uterine Perforation	2	2
Hyponatremia	2	2
Sepsis	2	2
Cardiac Arrest	2	2
Unspecified Tissue Injury	2	2
Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available	2	2
Abdominal Pain	1	1
Incomplete Induced Abortion	1	1
Intraoperative Cardiac Valve Injury	1	1
Peritoneal Laceration(s)	1	1
Ischemic Heart Disease	1	1
Embolism/Embolus	1	1
Atrial Fibrillation	1	1
Thrombosis/Thrombus	1	1
Exposure to Body Fluids	1	1
Septic Shock	1	1
Cardiogenic Shock	1	1
Pain	1	1
Unspecified Kidney or Urinary Problem	1	1
Bradycardia	1	1
Asystole	1	1
Bronchospasm	1	1
Loss of consciousness	1	1
Unspecified Vascular Problem	1	1
Airway Obstruction	1	1
Low Blood Pressure/ Hypotension	1	1
Internal Organ Perforation	1	1
Pulmonary Embolism	1	1
Urinary Tract Infection	1	1
Distress	1	1