TPLC - Total Product Life Cycle

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Premarket Reviews
Manufacturer	Decision
APPLIED MEDICAL RESOURCES CORP.
	SUBSTANTIALLY EQUIVALENT	1
COOPERSURGICAL, INC.
	SUBSTANTIALLY EQUIVALENT	1

Device Problems	MDRs with this Device Problem	Events in those MDRs
Break	26	26
Detachment of Device or Device Component	17	17
Melted	13	13
Entrapment of Device	7	7
Material Separation	6	6
Defective Device	5	5
Sparking	4	4
Material Rupture	4	4
Material Fragmentation	4	4
Adverse Event Without Identified Device or Use Problem	4	4
Thermal Decomposition of Device	3	3
Poor Quality Image	3	3
Material Twisted/Bent	3	3
Improper or Incorrect Procedure or Method	3	3
Defective Component	2	2
Component Missing	2	2
Material Puncture/Hole	2	2
Product Quality Problem	2	2
Leak/Splash	2	2
Inflation Problem	2	2
Excess Flow or Over-Infusion	2	2
Insufficient Information	2	2
Material Split, Cut or Torn	2	2
Device Fell	2	2
Appropriate Term/Code Not Available	1	1
Output Problem	1	1
Therapeutic or Diagnostic Output Failure	1	1
Unintended Movement	1	1
Difficult to Insert	1	1
Burst Container or Vessel	1	1
Crack	1	1
No Display/Image	1	1
Display or Visual Feedback Problem	1	1
Loose or Intermittent Connection	1	1
Mechanical Problem	1	1
Flaked	1	1
Fluid/Blood Leak	1	1
Overheating of Device	1	1
Increase in Pressure	1	1
Smoking	1	1
Use of Device Problem	1	1
Arcing	1	1
Fitting Problem	1	1
Material Perforation	1	1
Contamination /Decontamination Problem	1	1
Gas/Air Leak	1	1
Material Deformation	1	1
Material Integrity Problem	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	35	35
No Known Impact Or Consequence To Patient	32	32
Insufficient Information	15	15
No Patient Involvement	11	11
Foreign Body In Patient	8	8
Laceration(s)	7	7
No Consequences Or Impact To Patient	5	5
Device Embedded In Tissue or Plaque	4	4
Hemorrhage/Bleeding	2	2
Uterine Perforation	2	2
Menstrual Irregularities	1	1
Perforation	1	1
Injury	1	1
Bowel Perforation	1	1
No Information	1	1
Unspecified Tissue Injury	1	1