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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device light, surgical, ceiling mounted
Regulation Description Surgical lamp.
Product CodeFSY
Regulation Number 878.4580
Device Class 2

MDR Year MDR Reports MDR Events
2020 439 439
2021 380 380
2022 430 430
2023 663 663
2024 541 541
2025 124 124

Device Problems MDRs with this Device Problem Events in those MDRs
Detachment of Device or Device Component 1248 1248
Peeled/Delaminated 888 888
Corroded 320 320
Crack 174 174
Break 86 86
Flaked 78 78
Fluid/Blood Leak 65 65
No Apparent Adverse Event 55 55
Mechanical Problem 55 55
Degraded 54 54
Material Integrity Problem 52 52
Leak/Splash 44 44
Material Erosion 43 43
Fracture 42 42
Material Split, Cut or Torn 34 34
Material Separation 23 23
Insufficient Information 20 20
Grounding Malfunction 18 18
Use of Device Problem 18 18
Device Fell 16 16
Unintended Movement 15 15
Electrical /Electronic Property Problem 11 11
Moisture Damage 10 10
Temperature Problem 8 8
Improper or Incorrect Procedure or Method 6 6
Material Fragmentation 6 6
Overheating of Device 6 6
Failure to Clean Adequately 5 5
Radiation Output Problem 5 5
Unexpected Shutdown 5 5
Radiation Overexposure 5 5
Output Problem 5 5
Pitted 5 5
Appropriate Term/Code Not Available 4 4
Scratched Material 4 4
Adverse Event Without Identified Device or Use Problem 4 4
Contamination /Decontamination Problem 3 3
Excessive Heating 3 3
Device Dislodged or Dislocated 3 3
Smoking 3 3
Naturally Worn 3 3
Unintended Collision 3 3
Component Misassembled 2 2
Device Handling Problem 2 2
Difficult or Delayed Positioning 2 2
Positioning Failure 2 2
Off-Label Use 2 2
Loss of Power 2 2
Loose or Intermittent Connection 2 2
Structural Problem 2 2

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 1988 1988
No Consequences Or Impact To Patient 389 389
No Patient Involvement 80 80
No Known Impact Or Consequence To Patient 35 35
Burn(s) 20 20
Insufficient Information 17 17
Full thickness (Third Degree) Burn 10 10
Skin Discoloration 6 6
Laceration(s) 5 5
Concussion 5 5
Superficial (First Degree) Burn 5 5
Partial thickness (Second Degree) Burn 5 5
Bruise/Contusion 5 5
Pain 3 3
Scar Tissue 3 3
Foreign Body In Patient 3 3
Abrasion 3 3
Erythema 3 3
Injury 2 2
Skin Tears 2 2
Eye Injury 2 2
Headache 2 2
Burning Sensation 1 1
No Code Available 1 1
Bone Fracture(s) 1 1
Head Injury 1 1
Hematoma 1 1
Muscle/Tendon Damage 1 1
Unspecified Tissue Injury 1 1
Swelling/ Edema 1 1
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 1 1

Recalls
Manufacturer Recall Class Date Posted
1 DKK Dai-Ichi Shomei Co., Ltd. II Aug-14-2024
2 DKK Dai-Ichi Shomei Co., Ltd. II Oct-06-2023
3 Getinge Usa Sales Inc II Jan-19-2024
4 Getinge Usa Sales Inc II Jun-30-2022
5 Stryker Communications II Apr-09-2024
6 Stryker Communications II Mar-27-2020
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