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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Super Search Devices@FDA
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Device processor, cervical cytology slide, automated
Definition It is a system that is used to collect and prepare cervical cytology specimens for Pap stain-based screening for cervical cancer. The specimens are collected and rinsed into a liquid preservative fluid from which they are then automatically filtered and deposited in a thin-layer on a glass microscope slide. They are stained and screened by a cytotechnologist and cytopathologist.
Product CodeMKQ
Device Class 3

Premarket Approvals (PMA)
2017 2018 2019 2020 2021 2022
0 3 1 1 4 0

MDR Year MDR Reports MDR Events
2017 6 6
2018 2 2
2020 1 1
2021 24 24
2022 15 15

Device Problems MDRs with this Device Problem Events in those MDRs
Contamination 18 18
Incorrect, Inadequate or Imprecise Result or Readings 5 5
Device Markings/Labelling Problem 3 3
Microbial Contamination of Device 3 3
Structural Problem 3 3
Device Displays Incorrect Message 3 3
Contamination of Device Ingredient or Reagent 2 2
Device Operates Differently Than Expected 1 1
Facilities Issue 1 1
Adverse Event Without Identified Device or Use Problem 1 1
Unintended Movement 1 1
Appropriate Term/Code Not Available 1 1
Patient Data Problem 1 1
Non Reproducible Results 1 1
Inaccurate Information 1 1
Missing Information 1 1
Use of Device Problem 1 1
Defective Component 1 1
Signal Artifact/Noise 1 1
Device Reprocessing Problem 1 1
False Negative Result 1 1
Fire 1 1
Fluid/Blood Leak 1 1
Grounding Malfunction 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 39 39
No Known Impact Or Consequence To Patient 6 6
No Code Available 1 1
No Consequences Or Impact To Patient 1 1
Injury 1 1
Foreign Body In Patient 1 1

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