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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 540 540
2025 33 33

Device Problems MDRs with this Device Problem Events in those MDRs
Detachment of Device or Device Component 1216 1216
Peeled/Delaminated 841 841
Corroded 308 308
Crack 160 160
Break 81 81
Flaked 78 78
Fluid/Blood Leak 56 56
Mechanical Problem 55 55
Degraded 54 54
No Apparent Adverse Event 54 54
Material Integrity Problem 52 52
Leak/Splash 44 44
Material Erosion 42 42
Fracture 41 41
Material Split, Cut or Torn 30 30
Material Separation 22 22
Insufficient Information 19 19
Grounding Malfunction 18 18
Device Fell 16 16
Use of Device Problem 16 16
Unintended Movement 14 14
Electrical /Electronic Property Problem 11 11
Moisture Damage 9 9
Temperature Problem 8 8
Overheating of Device 6 6
Pitted 5 5
Radiation Output Problem 5 5
Failure to Clean Adequately 5 5
Output Problem 5 5
Unexpected Shutdown 5 5
Improper or Incorrect Procedure or Method 5 5
Material Fragmentation 5 5
Radiation Overexposure 5 5
Adverse Event Without Identified Device or Use Problem 4 4
Appropriate Term/Code Not Available 4 4
Scratched Material 4 4
Unintended Collision 3 3
Naturally Worn 3 3
Contamination /Decontamination Problem 3 3
Smoking 3 3
Device Dislodged or Dislocated 3 3
Device Handling Problem 2 2
Difficult or Delayed Positioning 2 2
Tear, Rip or Hole in Device Packaging 2 2
Structural Problem 2 2
Installation-Related Problem 2 2
Loose or Intermittent Connection 2 2
Defective Component 2 2
Component Missing 2 2
Off-Label Use 2 2

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 1901 1901
No Consequences Or Impact To Patient 389 389
No Patient Involvement 80 80
No Known Impact Or Consequence To Patient 35 35
Burn(s) 19 19
Insufficient Information 17 17
Full thickness (Third Degree) Burn 9 9
Bruise/Contusion 5 5
Superficial (First Degree) Burn 5 5
Laceration(s) 5 5
Partial thickness (Second Degree) Burn 5 5
Skin Discoloration 5 5
Concussion 5 5
Abrasion 3 3
Scar Tissue 3 3
Foreign Body In Patient 3 3
Erythema 3 3
Skin Tears 2 2
Injury 2 2
Pain 2 2
Eye Injury 2 2
Headache 2 2
Unspecified Tissue Injury 1 1
Burning Sensation 1 1
Hematoma 1 1
Head Injury 1 1
Swelling/ Edema 1 1
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 1 1
No Code Available 1 1
Bone Fracture(s) 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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