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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device lamp, surgical
Product CodeFTD
Regulation Number 878.4580
Device Class 2

MDR Year MDR Reports MDR Events
2019 80 80
2020 105 105
2021 65 65
2022 136 136
2023 260 260
2024 109 109

Device Problems MDRs with this Device Problem Events in those MDRs
Detachment of Device or Device Component 449 449
Peeled/Delaminated 146 146
Crack 94 94
Adverse Event Without Identified Device or Use Problem 64 64
Corroded 61 61
Fluid/Blood Leak 48 48
Fracture 31 31
Device Fell 26 26
Break 14 14
No Apparent Adverse Event 10 10
Material Split, Cut or Torn 7 7
Disconnection 7 7
Leak/Splash 7 7
Temperature Problem 4 4
Device Operational Issue 4 4
Flaked 4 4
Improper or Incorrect Procedure or Method 4 4
Loose or Intermittent Connection 3 3
Positioning Failure 3 3
Material Disintegration 3 3
Appropriate Term/Code Not Available 3 3
Unexpected Shutdown 3 3
Unintended Electrical Shock 2 2
Difficult or Delayed Positioning 2 2
Material Erosion 2 2
Grounding Malfunction 2 2
Moisture Damage 2 2
Unintended Collision 2 2
Structural Problem 2 2
Use of Device Problem 2 2
Difficult to Advance 2 2
Scratched Material 2 2
Output Problem 1 1
Power Problem 1 1
Material Integrity Problem 1 1
Mechanics Altered 1 1
Device-Device Incompatibility 1 1
Sparking 1 1
Pitted 1 1
Self-Activation or Keying 1 1
Unstable 1 1
Overheating of Device 1 1
Misassembled 1 1
Electrical /Electronic Property Problem 1 1
Contamination 1 1
Degraded 1 1
Sharp Edges 1 1
Device Handling Problem 1 1
Insufficient Information 1 1
Excessive Heating 1 1
Misassembly During Maintenance/Repair 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 539 539
No Consequences Or Impact To Patient 102 102
Irritation 25 25
Pain 19 19
No Known Impact Or Consequence To Patient 10 10
No Code Available 7 7
Perforation 7 7
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 6 6
No Patient Involvement 4 4
Radiation Exposure, Unintended 4 4
Hemorrhage/Bleeding 4 4
Burn(s) 3 3
Numbness 3 3
Skin Tears 3 3
Insufficient Information 3 3
No Information 2 2
Post Operative Wound Infection 2 2
Cardiac Perforation 2 2
Brain Injury 2 2
Stroke/CVA 2 2
Head Injury 1 1
Abrasion 1 1
Laceration(s) 1 1
Muscle Weakness 1 1
Nerve Damage 1 1
Discomfort 1 1
Scar Tissue 1 1
Scarring 1 1
Perforation of Vessels 1 1
Great Vessel Perforation 1 1
Burn, Thermal 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Baxter Healthcare Corporation II Jul-05-2024
2 Getinge Usa Sales Inc II Jan-19-2024
3 Maquet Cardiovascular Us Sales, Llc II Jun-21-2019
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