TPLC - Total Product Life Cycle

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Premarket Reviews
Manufacturer	Decision
APPLIED MEDICAL RESOURCES
	SUBSTANTIALLY EQUIVALENT	1
APPLIED MEDICAL RESOURCES CORP.
	SUBSTANTIALLY EQUIVALENT	1
COOPER SURGICAL INC.
	SUBSTANTIALLY EQUIVALENT	1
COOPERSURGICAL, INC.
	SUBSTANTIALLY EQUIVALENT	2
J.SINGH INSTRUMENTS
	SUBSTANTIALLY EQUIVALENT	1
LSI SOLUTIONS, INC.
	SUBSTANTIALLY EQUIVALENT	1
SURGITOOLS PTY LTD.
	SUBSTANTIALLY EQUIVALENT	1

Device Problems	MDRs with this Device Problem	Events in those MDRs
Break	30	30
Melted	19	19
Detachment of Device or Device Component	17	17
Material Separation	8	8
Entrapment of Device	7	7
Adverse Event Without Identified Device or Use Problem	7	7
Inflation Problem	6	6
Sparking	5	5
Insufficient Information	5	5
Defective Device	5	5
Material Fragmentation	5	5
Leak/Splash	5	5
Material Rupture	4	4
Thermal Decomposition of Device	3	3
Overheating of Device	3	3
Poor Quality Image	3	3
Material Twisted/Bent	3	3
Improper or Incorrect Procedure or Method	3	3
Smoking	3	3
Component Missing	3	3
Material Puncture/Hole	2	2
Use of Device Problem	2	2
Device Dislodged or Dislocated	2	2
Material Split, Cut or Torn	2	2
Therapeutic or Diagnostic Output Failure	2	2
Product Quality Problem	2	2
Device Fell	2	2
Defective Component	2	2
Excess Flow or Over-Infusion	2	2
Nonstandard Device	2	2
Loose or Intermittent Connection	2	2
Mechanics Altered	1	1
Flaked	1	1
Difficult to Insert	1	1
Malposition of Device	1	1
Material Perforation	1	1
Microbial Contamination of Device	1	1
Fluid/Blood Leak	1	1
Mechanical Problem	1	1
Crack	1	1
Display or Visual Feedback Problem	1	1
Output Problem	1	1
Mechanical Jam	1	1
Unintended Movement	1	1
Arcing	1	1
Fitting Problem	1	1
Material Deformation	1	1
Material Integrity Problem	1	1
Fire	1	1
Material Disintegration	1	1
Burst Container or Vessel	1	1
Gas/Air Leak	1	1
No Display/Image	1	1
Disassembly	1	1
Appropriate Term/Code Not Available	1	1
Increase in Pressure	1	1
Contamination /Decontamination Problem	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Known Impact Or Consequence To Patient	43	43
No Clinical Signs, Symptoms or Conditions	36	36
Insufficient Information	15	15
Laceration(s)	12	12
No Patient Involvement	11	11
Foreign Body In Patient	10	10
No Consequences Or Impact To Patient	9	9
Uterine Perforation	6	6
Hemorrhage/Bleeding	4	4
Device Embedded In Tissue or Plaque	4	4
No Information	3	3
Unspecified Infection	3	3
Burn(s)	2	2
Perforation	2	2
Bowel Perforation	1	1
Discomfort	1	1
Injury	1	1
Burn, Thermal	1	1
Adhesion(s)	1	1
Perforation of Vessels	1	1
Menstrual Irregularities	1	1
Pain	1	1
No Code Available	1	1
Unspecified Tissue Injury	1	1
Vascular Dissection	1	1