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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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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)
2009 2010 2011 2012 2013 2014 2015 2016 2017 2018 2019 2020 2021 2022 2023 2024
4 5 2 2 2 7 2 6 0 3 1 1 4 0 1 0

MDR Year MDR Reports MDR Events
2014 16 16
2015 22 22
2016 28 28
2017 6 6
2018 2 2
2020 1 1
2021 24 24
2022 17 17
2023 77 77
2024 9 9

Device Problems MDRs with this Device Problem Events in those MDRs
Leak/Splash 38 38
Contamination 28 28
Device Operates Differently Than Expected 26 26
Device Displays Incorrect Message 21 21
Device Markings/Labelling Problem 16 16
Break 15 15
Structural Problem 14 14
Incorrect, Inadequate or Imprecise Result or Readings 10 10
False Negative Result 10 10
Fluid/Blood Leak 5 5
Crack 5 5
Display Difficult to Read 5 5
Patient Data Problem 4 4
Microbial Contamination of Device 3 3
Improper Device Output 3 3
Data Problem 3 3
Improper or Incorrect Procedure or Method 3 3
Adverse Event Without Identified Device or Use Problem 3 3
Device Reprocessing Problem 2 2
Nonstandard Device 2 2
Device Alarm System 2 2
Complete Blockage 2 2
Application Program Problem 2 2
Contamination of Device Ingredient or Reagent 2 2
Reflux within Device 1 1
Failure to Obtain Sample 1 1
Chemical Spillage 1 1
Unintended Movement 1 1
Device Damaged by Another Device 1 1
Computer Operating System Problem 1 1
Device Handling Problem 1 1
Human Factors Issue 1 1
Inaccurate Information 1 1
Kinked 1 1
Grounding Malfunction 1 1
Manufacturing, Packaging or Shipping Problem 1 1
Unable to Obtain Readings 1 1
Insufficient Information 1 1
Noise, Audible 1 1
Device Or Device Fragments Location Unknown 1 1
Improper Flow or Infusion 1 1
Detachment of Device or Device Component 1 1
Burst Container or Vessel 1 1
Fire 1 1
Human-Device Interface Problem 1 1
Missing Information 1 1
Device Inoperable 1 1
Battery Problem 1 1
Facilities Issue 1 1
Defective Component 1 1
Non Reproducible Results 1 1
Use of Device Problem 1 1
Signal Artifact/Noise 1 1
Appropriate Term/Code Not Available 1 1
Suction Problem 1 1
Therapeutic or Diagnostic Output Failure 1 1
No Display/Image 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 127 127
No Known Impact Or Consequence To Patient 39 39
No Code Available 9 9
No Consequences Or Impact To Patient 9 9
Complaint, Ill-Defined 4 4
Venipuncture 4 4
No Patient Involvement 3 3
No Information 3 3
Device Embedded In Tissue or Plaque 1 1
Foreign Body In Patient 1 1
Injury 1 1
Tingling 1 1
Chills 1 1
Abdominal Pain 1 1
Hemorrhage/Bleeding 1 1
Pain 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Bd Diagnostic Systems Tripath II Mar-19-2009
2 Becton Dickinson & Co. II Dec-21-2016
3 Becton Dickinson & Co. II Aug-28-2013
4 Tripath Imaging, Inc. II Jul-26-2012
5 Tripath Imaging, Inc. III Jun-15-2012
6 Tripath Imaging, Inc. III May-21-2012
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