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	40	40
Packaging Problem	39	39
Defective Device	10	10
Device Packaging Compromised	9	9
Detachment of Device or Device Component	8	8
Break	6	6
Device Contamination with Chemical or Other Material	6	6
Defective Component	6	6
Failure to Power Up	5	5
Detachment Of Device Component	4	4
Device Operates Differently Than Expected	4	4
Manufacturing, Packaging or Shipping Problem	3	3
Device Disinfection Or Sterilization Issue	3	3
Product Quality Problem	2	2
Material Integrity Problem	2	2
Improper or Incorrect Procedure or Method	2	2
Delivered as Unsterile Product	2	2
Loss of or Failure to Bond	2	2
Structural Problem	1	1
Component Missing	1	1
Appropriate Term/Code Not Available	1	1
Insufficient Heating	1	1
Adverse Event Without Identified Device or Use Problem	1	1
Failure to Seal	1	1
Battery Problem	1	1
Tear, Rip or Hole in Device Packaging	1	1
Contamination	1	1
Material Discolored	1	1
Device Damaged Prior to Use	1	1
Loose or Intermittent Connection	1	1
Flaked	1	1
Component Falling	1	1
Fluid/Blood Leak	1	1
Device Or Device Fragments Location Unknown	1	1
Output Problem	1	1
Incorrect Device Or Component Shipped	1	1
Failure to Form Staple	1	1
Protective Measures Problem	1	1
Out-Of-Box Failure	1	1
Material Separation	1	1
Material Fragmentation	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	36	36
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