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 forceps
Regulation Description Manual surgical instrument for general use.
Product CodeHTD
Regulation Number 878.4800
Device Class 1

MDR Year MDR Reports MDR Events
2020 128 128
2021 156 156
2022 147 148
2023 155 156
2024 176 176
2025 123 123
2026 73 73

Device Problems MDRs with this Device Problem Events in those MDRs
Break 652 653
Device-Device Incompatibility 108 108
Material Integrity Problem 89 89
Mechanical Problem 30 30
Material Deformation 24 24
Material Twisted/Bent 20 20
Compatibility Problem 16 17
Material Fragmentation 14 14
Use of Device Problem 14 14
Contamination /Decontamination Problem 10 10
Difficult to Open or Close 10 10
Crack 7 7
Device Slipped 6 6
Entrapment of Device 6 6
No Apparent Adverse Event 6 6
Insufficient Information 4 4
Material Discolored 4 4
Fracture 4 4
Appropriate Term/Code Not Available 4 4
Mechanical Jam 4 4
Product Quality Problem 3 3
Component Missing 2 2
Detachment of Device or Device Component 2 2
Corroded 2 2
Output Problem 1 1
Physical Resistance/Sticking 1 1
Defective Component 1 1
Failure to Clean Adequately 1 1
Device Misassembled During Manufacturing /Shipping 1 1
Failure to Align 1 1
Failure to Cut 1 1
Adverse Event Without Identified Device or Use Problem 1 1
Material Separation 1 1
Residue After Decontamination 1 1
Device Reprocessing Problem 1 1
Nonstandard Device 1 1
Unexpected Therapeutic Results 1 1
Human-Device Interface Problem 1 1
Dull, Blunt 1 1
Noise, Audible 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 796 798
No Consequences Or Impact To Patient 66 66
Insufficient Information 44 44
No Patient Involvement 35 35
Foreign Body In Patient 9 9
No Known Impact Or Consequence To Patient 5 5
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 4 4
No Code Available 3 3
Vascular Dissection 1 1
Perforation 1 1
Osteopenia/ Osteoporosis 1 1
Burn(s) 1 1
Needle Stick/Puncture 1 1
Arteriosclerosis/ Atherosclerosis 1 1
Tissue Damage 1 1
Hemorrhage/Bleeding 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Aesculap Inc II Mar-11-2025
2 Sklar Instruments II Jan-16-2025
3 Stradis Medical, LLC dba Stradis Healthcare II Aug-18-2022
-
-