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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
2021 65 65
2022 136 136
2023 251 253
2024 144 144
2025 85 87
2026 9 9

Device Problems MDRs with this Device Problem Events in those MDRs
Detachment of Device or Device Component 440 441
Peeled/Delaminated 191 192
Crack 90 91
Corroded 53 53
Fluid/Blood Leak 47 47
Fracture 31 31
Device Contaminated at the User Facility 30 30
Device Fell 29 29
No Apparent Adverse Event 14 14
Material Split, Cut or Torn 9 9
Disconnection 8 8
Leak/Splash 8 8
Material Disintegration 7 7
Flaked 6 6
Adverse Event Without Identified Device or Use Problem 6 6
Improper or Incorrect Procedure or Method 4 4
Fail-Safe Did Not Operate 4 6
Break 4 4
Unexpected Shutdown 4 4
Positioning Failure 3 3
Unintended Electrical Shock 3 3
Loose or Intermittent Connection 3 3
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
Power Problem 2 2
Overheating of Device 2 2
Unintended Collision 2 2
Temperature Problem 2 2
Insufficient Information 1 1
Unintended Movement 1 1
Energy Output Problem 1 1
Material Integrity Problem 1 1
Failure to Clean Adequately 1 1
Contamination 1 1
Degraded 1 1
Material Twisted/Bent 1 1
Energy Spectrum Incorrect 1 1
Mechanics Altered 1 1
Sharp Edges 1 1
Misassembled 1 1
Pitted 1 1
Device Handling Problem 1 1
Device Emits Odor 1 1
Excessive Heating 1 1
Grounding Malfunction 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 649 652
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 7 7
No Consequences Or Impact To Patient 6 6
Insufficient Information 4 4
Skin Tears 3 3
Hemorrhage/Bleeding 3 3
Pain 2 2
Stroke/CVA 2 2
Partial thickness (Second Degree) Burn 2 2
Dyspnea 2 3
Head Injury 1 1
Hematoma 1 1
Numbness 1 1
Cardiac Perforation 1 1
Unspecified Musculoskeletal problem 1 1
Skin Burning Sensation 1 1
Crushing Injury 1 1
Abrasion 1 1
Burn(s) 1 1
Perforation 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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