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 camera, television, endoscopic, without audio
Regulation Description Surgical camera and accessories.
Product CodeFWF
Regulation Number 878.4160
Device Class 1

MDR Year MDR Reports MDR Events
2020 23 23
2021 28 28
2022 40 40
2023 25 25
2024 20 20
2025 25 25

Device Problems MDRs with this Device Problem Events in those MDRs
Display or Visual Feedback Problem 67 67
Output Problem 58 58
Power Problem 23 23
Physical Resistance/Sticking 17 17
Electrical /Electronic Property Problem 12 12
Break 11 11
Use of Device Problem 11 11
Blocked Connection 10 10
Intermittent Energy Output 8 8
Intermittent Continuity 7 7
Material Frayed 5 5
Intermittent Loss of Power 4 4
Scratched Material 3 3
Intermittent Capture 3 3
Detachment of Device or Device Component 3 3
Device Contaminated During Manufacture or Shipping 2 2
Mechanical Problem 2 2
Computer Software Problem 2 2
Appropriate Term/Code Not Available 2 2
No Visual Prompts/Feedback 1 1
Electrical Power Problem 1 1
Collapse 1 1
Difficult to Fold, Unfold or Collapse 1 1
Unintended Movement 1 1
Degraded 1 1
Material Fragmentation 1 1
Failure to Power Up 1 1
Complete Loss of Power 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 139 139
No Consequences Or Impact To Patient 16 16
Not Applicable 4 4
Intraoperative Pain 1 1
Swelling/ Edema 1 1

-
-