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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device stripper, vein, external
Product CodeDWQ
Regulation Number 870.4885
Device Class 2


Premarket Reviews
ManufacturerDecision
LEMAITRE VASCULAR INC.
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2014 1 1
2017 7 7
2018 36 36
2019 29 29
2020 5 5
2023 1 1
2024 1 1

Device Problems MDRs with this Device Problem Events in those MDRs
Failure to Conduct 31 31
Electrical /Electronic Property Problem 11 11
Device Inoperable 10 10
Device Stops Intermittently 5 5
Device Operational Issue 4 4
No Device Output 3 3
Failure to Auto Stop 2 2
Intermittent Loss of Power 2 2
Defective Component 1 1
Defective Device 1 1
Mechanical Jam 1 1
Mechanics Altered 1 1
Power Problem 1 1
Therapeutic or Diagnostic Output Failure 1 1
Unintended Movement 1 1
Appropriate Term/Code Not Available 1 1
Noise, Audible 1 1
Material Split, Cut or Torn 1 1
Overheating of Device 1 1
Loss of Power 1 1
Failure to Power Up 1 1
Difficult to Remove 1 1
Failure to Read Input Signal 1 1
Loose or Intermittent Connection 1 1
Disconnection 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Known Impact Or Consequence To Patient 44 44
No Information 21 21
No Patient Involvement 7 7
No Consequences Or Impact To Patient 3 3
No Clinical Signs, Symptoms or Conditions 2 2
Laceration(s) 2 2
Phlebitis 2 2
Foreign Body In Patient 1 1

Recalls
Manufacturer Recall Class Date Posted
1 LeMaitre Vascular, Inc. III Mar-18-2015
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