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 accessories, photographic, for endoscope (exclude light sources)
Regulation Description Endoscope and accessories.
Product CodeFEM
Regulation Number 876.1500
Device Class 1

MDR Year MDR Reports MDR Events
2020 54 54
2021 47 47
2022 109 109
2023 131 132
2024 108 108
2025 119 119
2026 37 37

Device Problems MDRs with this Device Problem Events in those MDRs
Display or Visual Feedback Problem 253 253
Break 171 172
Moisture Damage 40 40
Device-Device Incompatibility 34 34
Device Contaminated During Manufacture or Shipping 29 29
Detachment of Device or Device Component 23 23
Use of Device Problem 15 15
Unintended Movement 14 14
Smoking 12 12
Difficult to Open or Close 12 12
Material Deformation 11 11
Sparking 11 11
Degraded 11 11
Crack 9 9
Fire 9 9
Mechanical Jam 8 8
Mechanical Problem 8 8
Contamination /Decontamination Problem 5 5
Loss of Power 5 5
Scratched Material 5 5
Temperature Problem 5 5
Fracture 4 4
Failure to Power Up 4 4
Appropriate Device Problem Term/Code Not Available 4 4
Device Damaged Prior to Use 4 4
Corroded 3 3
Poor Quality Image 3 3
Electrical /Electronic Property Problem 3 3
Difficult to Advance 3 3
Difficult or Delayed Separation 3 3
Electrical Shorting 3 3
Thermal Decomposition of Device 3 3
Unintended Electrical Shock 2 2
Unintended Collision 2 2
Electrical Power Problem 2 2
Insufficient Device Problem Information 2 2
Power Problem 2 2
Physical Resistance/Sticking 2 2
Melted 2 2
Disconnection 2 2
Device Reprocessing Problem 2 2
Defective Device 2 2
Defective Component 2 2
Battery Problem 2 2
Unexpected Shutdown 1 1
Connection Problem 1 1
Complete Loss of Power 1 1
Material Integrity Problem 1 1
Device Contamination with Chemical or Other Material 1 1
Component Missing 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 542 543
No Consequences Or Impact To Patient 20 20
No Patient Involvement 15 15
No Information 10 10
No Known Impact Or Consequence To Patient 7 7
Insufficient Information 7 7
Unspecified Tissue Injury 4 4
Injury 4 4
Not Applicable 3 3
Electric Shock 3 3
Patient Problem/Medical Problem 2 2
Bruise/Contusion 2 2
Laceration(s) 1 1
Numbness 1 1
Burn(s) 1 1
Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available 1 1
Shock 1 1
Pain 1 1
Swelling/ Edema 1 1
Hyperextension 1 1
Burn, Thermal 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Ambu Inc. II Sep-22-2023
-
-