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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 254 254
2024 137 137

Device Problems MDRs with this Device Problem Events in those MDRs
Detachment of Device or Device Component 466 466
Peeled/Delaminated 157 157
Crack 104 104
Corroded 64 64
Adverse Event Without Identified Device or Use Problem 64 64
Fluid/Blood Leak 48 48
Fracture 32 32
Device Contaminated at the User Facility 30 30
Device Fell 28 28
Break 15 15
No Apparent Adverse Event 14 14
Material Split, Cut or Torn 10 10
Disconnection 8 8
Leak/Splash 8 8
Improper or Incorrect Procedure or Method 5 5
Temperature Problem 4 4
Unexpected Shutdown 4 4
Device Operational Issue 4 4
Flaked 4 4
Loose or Intermittent Connection 3 3
Appropriate Term/Code Not Available 3 3
Positioning Failure 3 3
Material Disintegration 3 3
Scratched Material 2 2
Use of Device Problem 2 2
Structural Problem 2 2
Moisture Damage 2 2
Difficult or Delayed Positioning 2 2
Difficult to Advance 2 2
Material Erosion 2 2
Unintended Electrical Shock 2 2
Unintended Collision 2 2
Degraded 1 1
Contamination 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
Failure to Clean Adequately 1 1
Material Integrity Problem 1 1
Insufficient Information 1 1
Power Problem 1 1
Excessive Heating 1 1
Grounding Malfunction 1 1
Overheating of Device 1 1
Self-Activation or Keying 1 1
Output Problem 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 561 561
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
Radiation Exposure, Unintended 4 4
No Patient Involvement 4 4
Hemorrhage/Bleeding 4 4
Burn(s) 3 3
Numbness 3 3
Insufficient Information 3 3
Skin Tears 3 3
Stroke/CVA 2 2
Brain Injury 2 2
No Information 2 2
Post Operative Wound Infection 2 2
Cardiac Perforation 2 2
Head Injury 1 1
Muscle Weakness 1 1
Abrasion 1 1
Scarring 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
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