TPLC - Total Product Life Cycle

• Device: ligator, hemorrhoidal
• Regulation Description: Hemorrhoidal ligator.
• Product Code: FHN
• Regulation Number: 876.4400
• Device Class: 2

Premarket Reviews
Manufacturer	Decision
BEIJING ZKSK TECHNOLOGY CO., LTD.
	SUBSTANTIALLY EQUIVALENT	1

MDR Year	MDR Reports	MDR Events
2021	16	16
2022	60	60
2023	47	47
2024	1	1
2025	7	7
2026	9	9

Device Problems	MDRs with this Device Problem	Events in those MDRs
Difficult to Remove	31	31
Break	23	23
Failure to Fire	15	15
Mechanical Problem	14	14
Failure to Disconnect	10	10
Separation Failure	9	9
Mechanical Jam	6	6
Physical Resistance/Sticking	5	5
Adverse Event Without Identified Device or Use Problem	5	5
Separation Problem	4	4
Material Twisted/Bent	4	4
Detachment of Device or Device Component	4	4
Unintended Movement	3	3
Failure to Unfold or Unwrap	3	3
Activation, Positioning or Separation Problem	2	2
Entrapment of Device	2	2
Difficult or Delayed Positioning	2	2
Difficult or Delayed Separation	2	2
Retraction Problem	2	2
Material Separation	2	2
Material Split, Cut or Torn	1	1
Failure to Eject	1	1
Misfire	1	1
Difficult or Delayed Activation	1	1
Lack of Effect	1	1
Material Protrusion/Extrusion	1	1
Nonstandard Device	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	104	104
Hemorrhage/Blood Loss/Bleeding	16	16
Foreign Body In Patient	14	14
Gastrointestinal Hemorrhage	3	3
Unspecified Tissue Injury	3	3
Fever	2	2
Abdominal Pain	1	1
Bowel Perforation	1	1
Perforation	1	1
Insufficient Information	1	1
Laceration(s)	1	1
Pain	1	1
Abscess	1	1
No Consequences Or Impact To Patient	1	1