TPLC - Total Product Life Cycle

show TPLC since

Device	anti fog solution and accessories, endoscopy
Definition	To prevent, reduce or eliminate condensation (fog) on endoscopic lens.
Product Code	OCT
Regulation Number	876.1500
Device Class	2

Premarket Reviews
Manufacturer	Decision
ADVANCED MEDICAL DESIGN CO., LTD
	SUBSTANTIALLY EQUIVALENT	1
BATRIK MEDICAL MANUFACTURING INC.
	SUBSTANTIALLY EQUIVALENT	1
JDI SURGICAL, INC.
	SUBSTANTIALLY EQUIVALENT	1
TURKUAZ SAGLIK HIZMETLERI MEDIKAL TEMIZLIK KIMYASAL URUNLER
	SUBSTANTIALLY EQUIVALENT	1

Device Problems	MDRs with this Device Problem	Events in those MDRs
Unsealed Device Packaging	38	38
Defective Device	8	8
Defective Component	5	5
Break	3	3
Failure to Power Up	3	3
Manufacturing, Packaging or Shipping Problem	3	3
Packaging Problem	3	3
Improper or Incorrect Procedure or Method	2	2
Loss of or Failure to Bond	2	2
Material Integrity Problem	2	2
Output Problem	1	1
Material Discolored	1	1
Insufficient Heating	1	1
Flaked	1	1
Loose or Intermittent Connection	1	1
Contamination	1	1
Product Quality Problem	1	1
Detachment of Device or Device Component	1	1
Material Separation	1	1
Appropriate Term/Code Not Available	1	1
Protective Measures Problem	1	1
Failure to Seal	1	1
Battery Problem	1	1
Material Fragmentation	1	1
Structural Problem	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	38	38
No Known Impact Or Consequence To Patient	17	17
Insufficient Information	9	9
No Patient Involvement	7	7
No Consequences Or Impact To Patient	4	4
Foreign Body In Patient	2	2
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	1	1
No Information	1	1