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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
2015 109 109
2016 231 231
2017 99 99
2018 97 97
2019 132 132
2020 128 128
2021 156 156
2022 147 147
2023 155 155
2024 127 127

Device Problems MDRs with this Device Problem Events in those MDRs
Break 908 908
Device Operates Differently Than Expected 90 90
Device-Device Incompatibility 84 84
Material Integrity Problem 82 82
Material Fragmentation 53 53
Component Missing 29 29
Mechanical Problem 20 20
Failure To Adhere Or Bond 19 19
Material Twisted/Bent 16 16
Material Deformation 15 15
Fracture 14 14
Detachment of Device or Device Component 13 13
Use of Device Problem 12 12
Contamination /Decontamination Problem 11 11
Compatibility Problem 10 10
Crack 9 9
Device Slipped 7 7
Detachment Of Device Component 7 7
Difficult to Open or Close 7 7
Insufficient Information 7 7
Appropriate Term/Code Not Available 7 7
Loose or Intermittent Connection 6 6
No Apparent Adverse Event 6 6
Material Frayed 5 5
Component Falling 5 5
Entrapment of Device 5 5
Mechanical Jam 5 5
Corroded 5 5
Naturally Worn 5 5
Physical Resistance/Sticking 4 4
Device Or Device Fragments Location Unknown 4 4
Product Quality Problem 4 4
Partial Blockage 4 4
Misassembly by Users 4 4
Adverse Event Without Identified Device or Use Problem 4 4
Material Separation 3 3
Bent 3 3
Dull, Blunt 2 2
Device Inoperable 2 2
Failure to Capture 2 2
Delivered as Unsterile Product 2 2
Failure to Align 2 2
Degraded 2 2
Defective Device 2 2
Sharp Edges 1 1
Device Damaged by Another Device 1 1
Failure to Cut 1 1
Device Difficult to Maintain 1 1
Positioning Failure 1 1
Sticking 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 572 572
No Known Impact Or Consequence To Patient 266 266
No Patient Involvement 237 237
No Consequences Or Impact To Patient 186 186
No Information 41 41
No Code Available 33 33
Insufficient Information 24 24
Device Embedded In Tissue or Plaque 10 10
Foreign Body In Patient 9 9
Not Applicable 5 5
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 4 4
Burn(s) 4 4
Patient Problem/Medical Problem 3 3
Sedation 3 3
Injury 2 2
Needle Stick/Puncture 2 2
Radiation Exposure, Unintended 1 1
Vascular Dissection 1 1
Perforation 1 1
Blood Loss 1 1
Osteopenia/ Osteoporosis 1 1
Pericardial Effusion 1 1
Paralysis 1 1
Awareness during Anaesthesia 1 1
Hemorrhage, Cerebral 1 1
Arteriosclerosis/ Atherosclerosis 1 1
Tissue Damage 1 1
Hemorrhage/Bleeding 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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