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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
probe, uptake, nuclear
Product Code
IZD
Regulation Number
892.1320
Device Class
1
Premarket Reviews
Manufacturer
Decision
SURGICEYE GMBH
SUBSTANTIALLY EQUIVALENT
3
MDR Year
MDR Reports
MDR Events
2014
1
1
2015
1
1
2016
1
1
2017
6
6
2018
4
4
2019
3
3
2020
1
1
2021
1
1
2022
3
3
2023
6
6
2024
3
3
Device Problems
MDRs with this Device Problem
Events in those MDRs
Mechanical Problem
12
12
Detachment of Device or Device Component
7
7
Detachment Of Device Component
5
5
Loss of or Failure to Bond
2
2
Component Falling
1
1
Fire
1
1
Device Operates Differently Than Expected
1
1
Therapeutic or Diagnostic Output Failure
1
1
Application Program Freezes, Becomes Nonfunctional
1
1
Failure to Reset
1
1
Incorrect, Inadequate or Imprecise Result or Readings
1
1
Material Separation
1
1
Device Inoperable
1
1
Defective Component
1
1
Failure to Calibrate
1
1
Patient Problems
MDRs with this Patient Problem
Events in those MDRs
No Clinical Signs, Symptoms or Conditions
11
11
No Consequences Or Impact To Patient
10
10
No Information
3
3
No Known Impact Or Consequence To Patient
2
2
Skin Discoloration
1
1
No Patient Involvement
1
1
Swelling
1
1
Insufficient Information
1
1
Recalls
Manufacturer
Recall Class
Date Posted
1
Capintec Inc
II
Mar-24-2020
2
Capintec Inc
II
Dec-04-2018
3
Capintec Inc
II
Sep-05-2012
4
Devicor Medical Products Inc
III
Oct-08-2020
5
Mirion Technologies (Capintec), Inc.
II
Feb-09-2024
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