TPLC - Total Product Life Cycle

• Device: anti fog solution and accessories, endoscopy
• Regulation Description: Endoscope and accessories.
• 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
BATRIK MEDICAL MANUFACTURING INC.
	SUBSTANTIALLY EQUIVALENT	1
JDI SURGICAL, INC.
	SUBSTANTIALLY EQUIVALENT	1
TURKUAZ SAGLIK HIZMETLERI MEDIKAL TEMIZLIK KIMYASAL URUNLER
	SUBSTANTIALLY EQUIVALENT	1

MDR Year	MDR Reports	MDR Events
2020	14	14
2021	16	16
2022	10	10
2023	13	13
2024	9	9
2025	4	4

Device Problems	MDRs with this Device Problem	Events in those MDRs
Unsealed Device Packaging	34	34
Defective Device	7	7
Defective Component	4	4
Improper or Incorrect Procedure or Method	2	2
Failure to Power Up	2	2
Manufacturing, Packaging or Shipping Problem	2	2
Packaging Problem	2	2
Loss of or Failure to Bond	2	2
Break	2	2
Insufficient Heating	1	1
Product Quality Problem	1	1
Output Problem	1	1
Appropriate Term/Code Not Available	1	1
Failure to Seal	1	1
Contamination	1	1
Material Discolored	1	1
Flaked	1	1
Structural Problem	1	1
Detachment of Device or Device Component	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	45	45
Insufficient Information	9	9
No Known Impact Or Consequence To Patient	6	6
No Patient Involvement	3	3
Foreign Body In Patient	1	1
No Consequences Or Impact To Patient	1	1
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	1	1

Recalls
Manufacturer		Recall Class	Date Posted
1	Sunstar Americas, Inc.	II	Mar-03-2022