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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
2014
1
1
2017
7
7
2018
36
36
2019
29
29
2020
5
5
2023
1
1
2024
2
2
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
Appropriate Term/Code Not Available
1
1
Power Problem
1
1
Overheating of Device
1
1
Disconnection
1
1
Material Split, Cut or Torn
1
1
Failure to Read Input Signal
1
1
Device Contamination with Body Fluid
1
1
Unintended Movement
1
1
Defective Component
1
1
Therapeutic or Diagnostic Output Failure
1
1
Defective Device
1
1
Difficult to Remove
1
1
Failure to Power Up
1
1
Loose or Intermittent Connection
1
1
Mechanical Jam
1
1
Loss of Power
1
1
Noise, Audible
1
1
Mechanics Altered
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 Clinical Signs, Symptoms or Conditions
3
3
No Consequences Or Impact To Patient
3
3
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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