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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device probe, uptake, nuclear
Product CodeIZD
Regulation Number 892.1320
Device Class 1


Premarket Reviews
ManufacturerDecision
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 4 4

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
Insufficient Information 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
Unspecified Tissue Injury 1 1
Insufficient Information 1 1
No Patient Involvement 1 1
Skin Discoloration 1 1
Swelling 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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