TPLC - Total Product Life Cycle

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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	35	35
Defective Device	8	8
Defective Component	5	5
Manufacturing, Packaging or Shipping Problem	3	3
Failure to Power Up	3	3
Break	3	3
Packaging Problem	3	3
Material Integrity Problem	2	2
Loss of or Failure to Bond	2	2
Improper or Incorrect Procedure or Method	2	2
Structural Problem	1	1
Output Problem	1	1
Battery Problem	1	1
Detachment of Device or Device Component	1	1
Contamination	1	1
Material Discolored	1	1
Flaked	1	1
Material Fragmentation	1	1
Insufficient Heating	1	1
Loose or Intermittent Connection	1	1
Product Quality Problem	1	1
Material Separation	1	1
Protective Measures Problem	1	1
Appropriate Term/Code Not Available	1	1
Failure to Seal	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	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
No Information	1	1
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	1	1