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
Leak/Splash	5	5
Material Fragmentation	5	5
Insufficient Information	5	5
Defective Device	5	5
Sparking	5	5
Material Rupture	4	4
Poor Quality Image	3	3
Overheating of Device	3	3
Smoking	3	3
Improper or Incorrect Procedure or Method	3	3
Component Missing	3	3
Thermal Decomposition of Device	3	3
Material Twisted/Bent	3	3
Therapeutic or Diagnostic Output Failure	2	2
Device Dislodged or Dislocated	2	2
Material Split, Cut or Torn	2	2
Device Fell	2	2
Loose or Intermittent Connection	2	2
Excess Flow or Over-Infusion	2	2
Defective Component	2	2
Use of Device Problem	2	2
Nonstandard Device	2	2
Material Puncture/Hole	2	2
Product Quality Problem	2	2
Increase in Pressure	1	1
Fitting Problem	1	1
Material Perforation	1	1
Microbial Contamination of Device	1	1
Arcing	1	1
Difficult to Insert	1	1
Mechanical Problem	1	1
Fire	1	1
Flaked	1	1
Fluid/Blood Leak	1	1
Burst Container or Vessel	1	1
Crack	1	1
Disassembly	1	1
Material Disintegration	1	1
No Display/Image	1	1
Display or Visual Feedback Problem	1	1
Gas/Air Leak	1	1
Material Deformation	1	1
Material Integrity Problem	1	1
Malposition of Device	1	1
Contamination /Decontamination Problem	1	1
Unintended Movement	1	1
Appropriate Term/Code Not Available	1	1
Mechanical Jam	1	1
Mechanics Altered	1	1
Output 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