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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 25 25

Device Problems MDRs with this Device Problem Events in those MDRs
Detachment of Device or Device Component 447 448
Peeled/Delaminated 201 202
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 8 8
Flaked 7 7
Adverse Event Without Identified Device or Use Problem 6 6
Improper or Incorrect Procedure or Method 4 4
Use of Device Problem 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
Difficult to Advance 2 2
Structural Problem 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
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
Energy Output Problem 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 663 666
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
Stroke/CVA 2 2
Foreign Body In Patient 2 2
Dyspnea 2 3
Pain 2 2
Partial thickness (Second Degree) Burn 2 2
Unspecified Musculoskeletal problem 1 1
Head Injury 1 1
Hematoma 1 1
Perforation 1 1
Abrasion 1 1
Crushing Injury 1 1
Burn(s) 1 1
Cardiac Perforation 1 1
Numbness 1 1
Great Vessel Perforation 1 1
Skin Burning Sensation 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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