TPLC - Total Product Life Cycle

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Device	forceps, biopsy, electric
Regulation Description	Endoscopic electrosurgical unit and accessories.
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
1. K220053 Diathermic Slitter (FlushKnife) DK2620JI and DK262 ...
HANGZHOU AGS MEDTECH CO., LTD.
	SUBSTANTIALLY EQUIVALENT	1
MICRO-TECH (NANJING) CO., LTD.
	SUBSTANTIALLY EQUIVALENT	1

Device Problems	MDRs with this Device Problem	Events in those MDRs
Unintended Movement	14	14
Adverse Event Without Identified Device or Use Problem	10	10
Illegible Information	7	7
Failure to Power Up	3	3
Material Twisted/Bent	3	3
Insufficient Heating	3	3
Mechanical Jam	3	3
Break	2	2
Mechanical Problem	2	2
Communication or Transmission Problem	2	2
Suction Failure	2	2
Failure to Align	2	2
Failure to Cut	2	2
Material Deformation	2	2
Complete Loss of Power	2	2
Overheating of Device	2	2
Intermittent Loss of Power	2	2
Dull, Blunt	2	2
Device Contaminated During Manufacture or Shipping	1	1
Unexpected Shutdown	1	1
Off-Label Use	1	1
Energy Output Problem	1	1
Failure to Clean Adequately	1	1
Use of Device Problem	1	1
Packaging Problem	1	1
Difficult to Open or Close	1	1
Failure to Deliver Shock/Stimulation	1	1
Noise, Audible	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	43	43
Perforation	6	6
Hemorrhage/Bleeding	6	6
No Consequences Or Impact To Patient	5	5
No Known Impact Or Consequence To Patient	3	3
Laceration(s) of Esophagus	2	2
Insufficient Information	2	2
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	1	1
Gastrointestinal Hemorrhage	1	1
Pain	1	1
Unspecified Tissue Injury	1	1
Bacterial Infection	1	1