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U.S. Department of Health and Human Services

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

MDR Year MDR Reports MDR Events
2020 105 105
2021 65 65
2022 136 136
2023 254 254
2024 145 145
2025 19 19

Device Problems MDRs with this Device Problem Events in those MDRs
Detachment of Device or Device Component 472 472
Peeled/Delaminated 171 171
Crack 108 108
Corroded 65 65
Fluid/Blood Leak 47 47
Fracture 31 31
Device Contaminated at the User Facility 30 30
Device Fell 26 26
No Apparent Adverse Event 14 14
Material Split, Cut or Torn 10 10
Adverse Event Without Identified Device or Use Problem 10 10
Disconnection 9 9
Break 9 9
Leak/Splash 8 8
Improper or Incorrect Procedure or Method 6 6
Unexpected Shutdown 4 4
Device Operational Issue 4 4
Flaked 4 4
Unintended Electrical Shock 3 3
Material Disintegration 3 3
Loose or Intermittent Connection 3 3
Positioning Failure 3 3
Temperature Problem 2 2
Unintended Collision 2 2
Grounding Malfunction 2 2
Power Problem 2 2
Difficult or Delayed Positioning 2 2
Structural Problem 2 2
Use of Device Problem 2 2
Scratched Material 2 2
Moisture Damage 2 2
Difficult to Advance 2 2
Material Erosion 2 2
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
Material Twisted/Bent 1 1
Degraded 1 1
Excessive Heating 1 1
Contamination 1 1
Overheating of Device 1 1
Self-Activation or Keying 1 1
Failure to Clean Adequately 1 1
Material Integrity Problem 1 1
Electrical /Electronic Property Problem 1 1
Device-Device Incompatibility 1 1
Sparking 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 587 587
No Consequences Or Impact To Patient 95 95
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 6 6
Perforation 5 5
Radiation Exposure, Unintended 4 4
No Patient Involvement 4 4
Insufficient Information 3 3
Skin Tears 3 3
Hemorrhage/Bleeding 3 3
Stroke/CVA 2 2
Cardiac Perforation 2 2
Pain 2 2
No Information 1 1
Head Injury 1 1
Abrasion 1 1
Crushing Injury 1 1
Burn, Thermal 1 1
Burn(s) 1 1
Numbness 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
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