Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • 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, ac-powered and accessories
Regulation Description Endoscope and accessories.
Product CodeGCP
Regulation Number 876.1500
Device Class 2

MDR Year MDR Reports MDR Events
2021 12 12
2022 26 26
2023 100 100
2024 108 109
2025 182 182

Device Problems MDRs with this Device Problem Events in those MDRs
Break 226 226
Detachment of Device or Device Component 52 52
Crack 18 18
Material Twisted/Bent 17 17
Contamination 13 13
Adverse Event Without Identified Device or Use Problem 12 12
Mechanical Problem 11 11
Fracture 11 11
Thermal Decomposition of Device 9 9
Poor Quality Image 8 8
Material Integrity Problem 8 8
Material Deformation 7 7
Melted 6 6
Physical Resistance/Sticking 6 6
Optical Problem 6 6
Loose or Intermittent Connection 5 5
Difficult to Open or Close 5 5
Device Reprocessing Problem 5 5
Labelling, Instructions for Use or Training Problem 5 5
Obstruction of Flow 5 5
Component Missing 5 5
Mechanical Jam 4 4
Dent in Material 4 4
Sparking 3 3
Material Separation 3 3
Scratched Material 3 3
Material Fragmentation 3 3
Failure to Seal 2 2
Electrical /Electronic Property Problem 2 3
Corroded 2 2
Degraded 2 2
Difficult to Fold, Unfold or Collapse 2 2
Device Markings/Labelling Problem 2 2
Image Display Error/Artifact 2 2
No Display/Image 2 2
Material Frayed 2 2
Optical Distortion 1 1
Failure to Clean Adequately 1 1
Failure to Align 1 1
Defective Component 1 1
Electro-Static Discharge 1 1
Unintended Movement 1 1
Pitted 1 1
Material Disintegration 1 1
Device Handling Problem 1 1
Peeled/Delaminated 1 1
Activation Problem 1 1
Activation Failure 1 1
Output Problem 1 1
Fire 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 389 389
Foreign Body In Patient 13 13
Burn(s) 7 7
Sepsis 5 5
Urinary Tract Infection 5 5
Urethral Stenosis/Stricture 3 3
Urinary Incontinence 2 2
Insufficient Information 2 2
Hemorrhage/Bleeding 2 2
Internal Organ Perforation 2 3
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 1 1
Hyponatremia 1 1
Perforation 1 1
Rupture 1 1
No Consequences Or Impact To Patient 1 1
Device Embedded In Tissue or Plaque 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Olympus Corporation of the Americas II Nov-08-2024
-
-