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
MEDLINE INDUSTRIES, INC.
	SUBSTANTIALLY EQUIVALENT	1
MINIMALLY INVASIVE DEVICES LLC
	SUBSTANTIALLY EQUIVALENT	1
MISDER, LLC
	SUBSTANTIALLY EQUIVALENT	1
SIO2 NANOTECH, LLC
	SUBSTANTIALLY EQUIVALENT	1
TURKUAZ SAGLIK HIZMETLERI MEDIKAL TEMIZLIK KIMYASAL URUNLER
	SUBSTANTIALLY EQUIVALENT	1
UNIMAX MEDICAL SYSTEMS, INC.
	SUBSTANTIALLY EQUIVALENT	1

Device Problems	MDRs with this Device Problem	Events in those MDRs
Unsealed Device Packaging	39	39
Packaging Problem	39	39
Defective Device	10	10
Device Packaging Compromised	9	9
Detachment of Device or Device Component	8	8
Defective Component	6	6
Break	6	6
Device Contamination with Chemical or Other Material	6	6
Failure to Power Up	5	5
Detachment Of Device Component	4	4
Device Operates Differently Than Expected	4	4
Device Disinfection Or Sterilization Issue	3	3
Manufacturing, Packaging or Shipping Problem	3	3
Material Integrity Problem	2	2
Product Quality Problem	2	2
Loss of or Failure to Bond	2	2
Delivered as Unsterile Product	2	2
Improper or Incorrect Procedure or Method	2	2
Device Damaged Prior to Use	1	1
Material Separation	1	1
Component Falling	1	1
Contamination	1	1
Material Discolored	1	1
Flaked	1	1
Fluid/Blood Leak	1	1
Material Fragmentation	1	1
Insufficient Heating	1	1
Loose or Intermittent Connection	1	1
Adverse Event Without Identified Device or Use Problem	1	1
Output Problem	1	1
Protective Measures Problem	1	1
Appropriate Term/Code Not Available	1	1
Failure to Seal	1	1
Device Or Device Fragments Location Unknown	1	1
Battery Problem	1	1
Component Missing	1	1
Out-Of-Box Failure	1	1
Tear, Rip or Hole in Device Packaging	1	1
Structural Problem	1	1
Failure to Form Staple	1	1
Incorrect Device Or Component Shipped	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Known Impact Or Consequence To Patient	48	48
No Clinical Signs, Symptoms or Conditions	35	35
No Patient Involvement	34	34
No Information	11	11
Insufficient Information	9	9
No Consequences Or Impact To Patient	8	8
Foreign Body In Patient	3	3
No Code Available	2	2
Radiation Exposure, Unintended	1	1
Not Applicable	1	1
Burn(s)	1	1
Death	1	1
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	1	1