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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device forceps
Product CodeHTD
Regulation Number 878.4800
Device Class 1

MDR Year MDR Reports MDR Events
2018 97 97
2019 132 132
2020 128 128
2021 156 156
2022 147 147
2023 141 141

Device Problems MDRs with this Device Problem Events in those MDRs
Break 561 561
Device-Device Incompatibility 67 67
Material Integrity Problem 65 65
Mechanical Problem 19 19
Material Twisted/Bent 15 15
Material Deformation 13 13
Contamination /Decontamination Problem 9 9
Material Fragmentation 8 8
Use of Device Problem 7 7
Fracture 6 6
Detachment of Device or Device Component 6 6
Mechanical Jam 5 5
Entrapment of Device 5 5
Crack 5 5
Compatibility Problem 5 5
Misassembly by Users 4 4
Insufficient Information 4 4
Appropriate Term/Code Not Available 4 4
Physical Resistance/Sticking 4 4
Partial Blockage 4 4
Corroded 4 4
Difficult to Open or Close 4 4
Device Operates Differently Than Expected 3 3
Dull, Blunt 2 2
Component Missing 2 2
Degraded 2 2
Delivered as Unsterile Product 2 2
Product Quality Problem 2 2
Device Slipped 2 2
Device Stops Intermittently 1 1
Unexpected Therapeutic Results 1 1
Device Inoperable 1 1
Device Damaged Prior to Use 1 1
Grounding Malfunction 1 1
Insufficient Heating 1 1
Electrical /Electronic Property Problem 1 1
Component Falling 1 1
Residue After Decontamination 1 1
Human-Device Interface Problem 1 1
Adverse Event Without Identified Device or Use Problem 1 1
Output Problem 1 1
Scratched Material 1 1
Failure to Align 1 1
Failure to Cut 1 1
Device Or Device Fragments Location Unknown 1 1
Device Damaged by Another Device 1 1
Sharp Edges 1 1
Failure to Clean Adequately 1 1
No Apparent Adverse Event 1 1
Manufacturing, Packaging or Shipping Problem 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 450 450
No Consequences Or Impact To Patient 172 172
No Patient Involvement 102 102
No Known Impact Or Consequence To Patient 39 39
No Code Available 20 20
Foreign Body In Patient 8 8
Insufficient Information 4 4
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 4 4
Not Applicable 3 3
Patient Problem/Medical Problem 2 2
Burn(s) 2 2
Hemorrhage/Bleeding 1 1
Perforation 1 1
Tissue Damage 1 1
Osteopenia/ Osteoporosis 1 1
Needle Stick/Puncture 1 1
Vascular Dissection 1 1
Device Embedded In Tissue or Plaque 1 1
Arteriosclerosis/ Atherosclerosis 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Baxter Healthcare Corporation II Dec-22-2018
2 ConvaTec, Inc II Mar-21-2019
3 Stradis Medical, LLC dba Stradis Healthcare II Aug-18-2022
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