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TPLC - Total Product Life Cycle
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TPLC
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show TPLC since
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2024
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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
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