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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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Device
stripper, vein, external
Product Code
DWQ
Regulation Number
870.4885
Device Class
2
Premarket Reviews
Manufacturer
Decision
LEMAITRE VASCULAR INC.
SUBSTANTIALLY EQUIVALENT
1
MDR Year
MDR Reports
MDR Events
2019
29
29
2020
5
5
2023
1
1
Device Problems
MDRs with this Device Problem
Events in those MDRs
Failure to Conduct
11
11
Electrical /Electronic Property Problem
7
7
No Device Output
3
3
Intermittent Loss of Power
2
2
Loss of Power
1
1
Failure to Power Up
1
1
Unintended Movement
1
1
Defective Device
1
1
Overheating of Device
1
1
Noise, Audible
1
1
Mechanics Altered
1
1
Loose or Intermittent Connection
1
1
Material Split, Cut or Torn
1
1
Therapeutic or Diagnostic Output Failure
1
1
Appropriate Term/Code Not Available
1
1
Failure to Read Input Signal
1
1
Power Problem
1
1
Defective Component
1
1
Patient Problems
MDRs with this Patient Problem
Events in those MDRs
No Known Impact Or Consequence To Patient
23
23
No Patient Involvement
5
5
No Information
4
4
No Consequences Or Impact To Patient
2
2
No Clinical Signs, Symptoms or Conditions
1
1
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