TPLC - Total Product Life Cycle

• Device: anoscope and accessories
• Definition: To examine and perform procedures within the anus and rectum.
• Product Code: FER
• Regulation Number: 876.1500
• Device Class: 2

Premarket Reviews
Manufacturer	Decision
APPLIED MEDICAL RESOURCES
	SUBSTANTIALLY EQUIVALENT	1
WELL CARE (WUHAN) MEDICAL TECHNOLOGY CO., LTD
	SUBSTANTIALLY EQUIVALENT	1

MDR Year	MDR Reports	MDR Events
2019	15	15
2020	18	18
2021	3	3
2022	3	3
2023	6	6

Device Problems	MDRs with this Device Problem	Events in those MDRs
Patient-Device Incompatibility	18	18
Unintended Movement	9	9
Detachment of Device or Device Component	7	7
No Apparent Adverse Event	4	4
Adverse Event Without Identified Device or Use Problem	4	4
Suction Problem	3	3
Difficult or Delayed Positioning	3	3
Tear, Rip or Hole in Device Packaging	2	2
Activation Failure	2	2
Use of Device Problem	1	1
Inadequacy of Device Shape and/or Size	1	1
Activation, Positioning or Separation Problem	1	1
Unclear Information	1	1
Insufficient Information	1	1
Contamination /Decontamination Problem	1	1
Material Perforation	1	1
Improper or Incorrect Procedure or Method	1	1
Defective Device	1	1
Biocompatibility	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	19	19
No Known Impact Or Consequence To Patient	18	18
No Consequences Or Impact To Patient	8	8
No Code Available	3	3
Insufficient Information	2	2
No Information	1	1
Blood Loss	1	1
Intracranial Hemorrhage	1	1
No Patient Involvement	1	1
Pain	1	1
Skin Tears	1	1
Hemorrhage/Bleeding	1	1

Recalls
Manufacturer		Recall Class	Date Posted
1	Applied Medical Resources Corp	II	Nov-21-2019