TPLC - Total Product Life Cycle

• Device: forceps, biopsy, electric
• Product Code: KGE
• Regulation Number: 876.4300
• Device Class: 2

Premarket Reviews
Manufacturer	Decision
BEIJING ZKSK TECHNOLOGY CO.,LTD
	SUBSTANTIALLY EQUIVALENT	1
FUJIFILM CORPORATION
	SUBSTANTIALLY EQUIVALENT	1
HANGZHOU AGS MEDTECH CO., LTD.
	SUBSTANTIALLY EQUIVALENT	1
MICRO-TECH (NANJING) CO., LTD.
	SUBSTANTIALLY EQUIVALENT	1
STERIS CORPORATION
	SUBSTANTIALLY EQUIVALENT	1

MDR Year	MDR Reports	MDR Events
2019	15	15
2020	7	7
2021	24	24
2022	16	16
2023	8	8
2024	2	2

Device Problems	MDRs with this Device Problem	Events in those MDRs
Adverse Event Without Identified Device or Use Problem	11	11
Unintended Movement	10	10
Illegible Information	7	7
Failure to Align	7	7
Difficult to Open or Close	4	4
Material Twisted/Bent	3	3
Mechanical Jam	3	3
Use of Device Problem	3	3
Insufficient Heating	3	3
Failure to Power Up	3	3
Mechanical Problem	2	2
Overheating of Device	2	2
Dull, Blunt	2	2
Failure to Cut	2	2
Communication or Transmission Problem	2	2
Material Deformation	2	2
Suction Failure	2	2
Complete Loss of Power	2	2
Intermittent Loss of Power	2	2
Unexpected Shutdown	1	1
No Apparent Adverse Event	1	1
Noise, Audible	1	1
Output Problem	1	1
Packaging Problem	1	1
Therapeutic or Diagnostic Output Failure	1	1
Failure to Clean Adequately	1	1
Device Contaminated During Manufacture or Shipping	1	1
Material Separation	1	1
Break	1	1
Failure to Deliver Shock/Stimulation	1	1
Failure to Deliver Energy	1	1
Fracture	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	36	36
No Consequences Or Impact To Patient	14	14
Hemorrhage/Bleeding	9	9
Perforation	6	6
No Known Impact Or Consequence To Patient	3	3
Insufficient Information	2	2
Pain	2	2
Blood Loss	2	2
No Patient Involvement	1	1
Laceration(s) of Esophagus	1	1
Vomiting	1	1
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	1	1
Unspecified Tissue Injury	1	1
Bacterial Infection	1	1