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 laryngoscope, endoscope
Regulation Description Endoscope and accessories.
Product CodeGCI
Regulation Number 876.1500
Device Class 2

MDR Year MDR Reports MDR Events
2021 96 96
2022 102 102
2023 101 101
2024 119 119
2025 122 122
2026 59 59

Device Problems MDRs with this Device Problem Events in those MDRs
Material Split, Cut or Torn 414 414
Detachment of Device or Device Component 111 111
Material Separation 60 60
Break 35 35
Adverse Event Without Identified Device or Use Problem 12 12
Material Rupture 9 9
Insufficient Device Problem Information 6 6
Difficult to Remove 5 5
Device Difficult to Maintain 4 4
Display or Visual Feedback Problem 4 4
Difficult to Insert 3 3
Mechanics Altered 3 3
Product Quality Problem 3 3
No Apparent Adverse Event 3 3
Leak/Splash 2 2
No Display/Image 1 1
Mechanical Problem 1 1
Smoking 1 1
Failure to Align 1 1
Material Twisted/Bent 1 1
Material Protrusion/Extrusion 1 1
Difficult to Open or Close 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 425 425
Insufficient Information 112 112
Laceration(s) 24 24
Foreign Body In Patient 23 23
Unspecified Tissue Injury 22 22
Unintended Radiation Exposure 8 8
Bacterial Infection 7 7
Tissue Breakdown 6 6
Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available 5 5
Exposure to Body Fluids 3 3
Vascular Dissection 2 2
Unspecified Infection 1 1
Purulent Discharge 1 1
Rupture 1 1
Wound Infection 1 1
Hemorrhage/Blood Loss/Bleeding 1 1
Device Embedded In Tissue or Plaque 1 1

-
-