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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
2018 16 16
2019 80 80
2020 105 105
2021 65 65
2022 136 136
2023 260 260
2024 132 132

Device Problems MDRs with this Device Problem Events in those MDRs
Detachment of Device or Device Component 470 470
Peeled/Delaminated 154 154
Crack 103 103
Adverse Event Without Identified Device or Use Problem 70 70
Corroded 63 63
Fluid/Blood Leak 48 48
Fracture 31 31
Device Fell 27 27
Break 15 15
No Apparent Adverse Event 10 10
Material Split, Cut or Torn 9 9
Disconnection 8 8
Leak/Splash 7 7
Improper or Incorrect Procedure or Method 5 5
Flaked 5 5
Temperature Problem 4 4
Device Operational Issue 4 4
Loose or Intermittent Connection 3 3
Appropriate Term/Code Not Available 3 3
Positioning Failure 3 3
Material Disintegration 3 3
Unexpected Shutdown 3 3
Material Integrity Problem 2 2
Contamination 2 2
Moisture Damage 2 2
Scratched Material 2 2
Use of Device Problem 2 2
Structural Problem 2 2
Difficult to Advance 2 2
Difficult or Delayed Positioning 2 2
Material Erosion 2 2
Unintended Electrical Shock 2 2
Grounding Malfunction 2 2
Detachment Of Device Component 2 2
Unintended Collision 2 2
Failure to Clean Adequately 1 1
Degraded 1 1
Insufficient Information 1 1
Failure to Power Up 1 1
Material Twisted/Bent 1 1
Mechanics Altered 1 1
Sharp Edges 1 1
Misassembly During Maintenance/Repair 1 1
Misassembled 1 1
Pitted 1 1
Device Handling Problem 1 1
Power Problem 1 1
Output Problem 1 1
Excessive Heating 1 1
Intermittent Continuity 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 562 562
No Consequences Or Impact To Patient 105 105
Irritation 25 25
Pain 19 19
No Known Impact Or Consequence To Patient 13 13
Perforation 11 11
No Code Available 7 7
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 6 6
Hemorrhage/Bleeding 5 5
Radiation Exposure, Unintended 4 4
No Patient Involvement 4 4
No Information 3 3
Burn(s) 3 3
Cardiac Perforation 3 3
Numbness 3 3
Insufficient Information 3 3
Skin Tears 3 3
Stroke/CVA 2 2
Brain Injury 2 2
Scarring 2 2
Post Operative Wound Infection 2 2
Injury 2 2
Death 1 1
Head Injury 1 1
Muscle Weakness 1 1
Abrasion 1 1
Burn, Thermal 1 1
Nerve Damage 1 1
Discomfort 1 1
Laceration(s) 1 1
Scar Tissue 1 1
Perforation of Vessels 1 1
Great Vessel Perforation 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
4 Maquet SAS II Jul-19-2018
5 Maquet SAS II May-25-2018
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