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 applier, staple, surgical,
Regulation Description Manual surgical instrument for general use.
Product CodeGEF
Regulation Number 878.4800
Device Class 1

MDR Year MDR Reports MDR Events
2021 20 20
2022 18 18
2023 18 18
2024 44 44
2025 55 55
2026 10 10

Device Problems MDRs with this Device Problem Events in those MDRs
Device-Device Incompatibility 128 128
Material Deformation 16 16
Premature Activation 15 15
Use of Device Problem 10 10
Break 6 6
Unintended Movement 3 3
Detachment of Device or Device Component 3 3
Device Damaged Prior to Use 2 2
Difficult to Advance 2 2
Appropriate Term/Code Not Available 2 2
Device Contaminated During Manufacture or Shipping 1 1
Entrapment of Device 1 1
Shipping Damage or Problem 1 1
Mechanical Jam 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 164 164
Insufficient Information 1 1

-
-