• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

New Search show TPLC since Back to Search Results
Device endoscope, flexible
Product CodeGCQ
Regulation Number 876.1500
Device Class 2

MDR Year MDR Reports MDR Events
2017 1 1
2018 7 7
2021 15 15
2022 6 6

Device Problems MDRs with this Device Problem Events in those MDRs
Microbial Contamination of Device 4 4
Adverse Event Without Identified Device or Use Problem 4 4
Optical Distortion 4 4
Unintended Movement 3 3
Erratic or Intermittent Display 3 3
Fluid Leak 3 3
Device Markings/Labelling Problem 2 2
Collapse 2 2
Break 1 1
Optical Problem 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
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 18 18
Unspecified Infection 8 8
Device Overstimulation of Tissue 1 1
No Consequences Or Impact To Patient 1 1
No Patient Involvement 1 1
No Known Impact Or Consequence To Patient 1 1

-
-