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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 1

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 23 23

Device Problems MDRs with this Device Problem Events in those MDRs
Leak/Splash 43 43
Contamination 31 31
Device Operates Differently Than Expected 26 26
Device Displays Incorrect Message 21 21
Structural Problem 18 18
Device Markings/Labelling Problem 16 16
Break 15 15
False Negative Result 12 12
Incorrect, Inadequate or Imprecise Result or Readings 10 10
Display Difficult to Read 5 5
Crack 5 5
Fluid/Blood Leak 5 5
Patient Data Problem 4 4
Improper Device Output 3 3
Improper or Incorrect Procedure or Method 3 3
Adverse Event Without Identified Device or Use Problem 3 3
Microbial Contamination of Device 3 3
Data Problem 3 3
Application Program Problem 2 2
Device Alarm System 2 2
Complete Blockage 2 2
Device Reprocessing Problem 2 2
Nonstandard Device 2 2
Contamination of Device Ingredient or Reagent 2 2
Suction Problem 1 1
Grounding Malfunction 1 1
Inaccurate Information 1 1
Device Or Device Fragments Location Unknown 1 1
Human-Device Interface Problem 1 1
Detachment of Device or Device Component 1 1
Missing Information 1 1
Device Damaged by Another Device 1 1
Noise, Audible 1 1
Device Inoperable 1 1
Reflux within Device 1 1
Fire 1 1
Burst Container or Vessel 1 1
No Display/Image 1 1
Facilities Issue 1 1
Appropriate Term/Code Not Available 1 1
Computer Operating System Problem 1 1
Device Handling Problem 1 1
Chemical Spillage 1 1
Use of Device Problem 1 1
Improper Flow or Infusion 1 1
Human Factors Issue 1 1
Unable to Obtain Readings 1 1
Battery Problem 1 1
Therapeutic or Diagnostic Output Failure 1 1
Failure to Obtain Sample 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 141 141
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 Information 3 3
No Patient Involvement 3 3
Abdominal Pain 1 1
Tingling 1 1
Chills 1 1
Injury 1 1
Foreign Body In Patient 1 1
Pain 1 1
Hemorrhage/Bleeding 1 1
Device Embedded In Tissue or Plaque 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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