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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device endoscope, flexible
Product CodeGCQ
Regulation Number 876.1500
Device Class 2

MDR Year MDR Reports MDR Events
2015 2 2
2016 1 1
2017 1 1
2018 7 7
2021 15 15
2022 9 9
2023 2 2

Device Problems MDRs with this Device Problem Events in those MDRs
Adverse Event Without Identified Device or Use Problem 5 5
Optical Distortion 4 4
Device Reprocessing Problem 4 4
Microbial Contamination of Device 4 4
Erratic or Intermittent Display 3 3
Fluid/Blood Leak 3 3
Unintended Movement 3 3
Collapse 2 2
Device Markings/Labelling Problem 2 2
Break 1 1
Insufficient Information 1 1
Optical Problem 1 1
Inadequate Instructions for Healthcare Professional 1 1
Leak/Splash 1 1
Loose or Intermittent Connection 1 1
Misconnection 1 1
Poor Quality Image 1 1
Biocompatibility 1 1
Blocked Connection 1 1
Contamination /Decontamination Problem 1 1
Communication or Transmission Problem 1 1
Detachment of Device or Device Component 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 23 23
Unspecified Infection 8 8
Device Overstimulation of Tissue 1 1
Septic Shock 1 1
No Consequences Or Impact To Patient 1 1
No Patient Involvement 1 1
No Known Impact Or Consequence To Patient 1 1
No Information 1 1
Death 1 1
Fever 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Integrated Medical Systems Inc II Feb-25-2016
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