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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
Product CodeFSY
Regulation Number 878.4580
Device Class 2

MDR Year MDR Reports MDR Events
2018 316 316
2019 444 444
2020 439 439
2021 380 380
2022 430 430
2023 422 422

Device Problems MDRs with this Device Problem Events in those MDRs
Detachment of Device or Device Component 987 987
Peeled/Delaminated 602 602
Corroded 249 249
Crack 202 202
Degraded 140 140
Flaked 130 130
Material Integrity Problem 115 115
Break 111 111
Mechanical Problem 102 102
Material Fragmentation 76 76
Device Fell 73 73
Material Erosion 42 42
Leak/Splash 36 36
Component Falling 28 28
Fluid/Blood Leak 24 24
Fracture 21 21
No Apparent Adverse Event 18 18
Material Separation 17 17
Grounding Malfunction 16 16
Detachment Of Device Component 15 15
Temperature Problem 14 14
Unintended Movement 13 13
Component Missing 13 13
Device Issue 13 13
Electrical /Electronic Property Problem 12 12
Use of Device Problem 11 11
Material Disintegration 10 10
Appropriate Term/Code Not Available 9 9
Adverse Event Without Identified Device or Use Problem 9 9
Physical Property Issue 8 8
Material Split, Cut or Torn 8 8
Loose or Intermittent Connection 8 8
Improper or Incorrect Procedure or Method 7 7
Smoking 7 7
Device Dislodged or Dislocated 7 7
Overheating of Device 6 6
Burst Container or Vessel 5 5
Contamination /Decontamination Problem 5 5
Structural Problem 5 5
Defective Device 5 5
Pitted 5 5
Radiation Overexposure 5 5
Radiation Output Problem 5 5
Output Problem 5 5
Insufficient Information 5 5
Misassembly During Maintenance/Repair 4 4
Defective Component 4 4
Contamination 4 4
Unintended Collision 4 4
Moisture Damage 4 4
Particulates 3 3
Loss of Power 3 3
Device Contamination with Chemical or Other Material 3 3
Installation-Related Problem 3 3
Device Damaged by Another Device 3 3
Failure to Clean Adequately 3 3
Unexpected Shutdown 3 3
Patient Device Interaction Problem 2 2
Component Misassembled 2 2
Separation Problem 2 2
Device Handling Problem 2 2
Naturally Worn 2 2
Power Problem 2 2
Protective Measures Problem 2 2
Material Deformation 2 2
Device Operates Differently Than Expected 2 2
Sparking 2 2
Off-Label Use 2 2
Tear, Rip or Hole in Device Packaging 2 2
Misassembled 2 2
Device Emits Odor 1 1
No Device Output 1 1
Melted 1 1
Circuit Failure 1 1
Thermal Decomposition of Device 1 1
Accessory Incompatible 1 1
Unintended Arm Motion 1 1
Bent 1 1
Fire 1 1
Material Discolored 1 1
Decoupling 1 1
Device Tipped Over 1 1
Separation Failure 1 1
Device Damaged Prior to Use 1 1
Device Slipped 1 1
Battery Problem 1 1
Component or Accessory Incompatibility 1 1
Connection Problem 1 1
Contamination of Device Ingredient or Reagent 1 1
Manufacturing, Packaging or Shipping Problem 1 1
Inadequate Lighting 1 1
Compatibility Problem 1 1
Environmental Compatibility Problem 1 1
Positioning Problem 1 1
Activation Failure 1 1
Misassembly by Users 1 1
Torn Material 1 1
Misassembled During Installation 1 1
Inadequate Lubrication 1 1
Ejection Problem 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 1124 1124
No Consequences Or Impact To Patient 579 579
No Known Impact Or Consequence To Patient 508 508
No Patient Involvement 154 154
Injury 17 17
Burn(s) 13 13
Insufficient Information 12 12
No Information 10 10
Bruise/Contusion 6 6
Skin Discoloration 5 5
No Code Available 4 4
Foreign Body In Patient 3 3
Concussion 3 3
Burn, Thermal 3 3
Tissue Damage 2 2
Eye Injury 2 2
Laceration(s) 2 2
Head Injury 2 2
Headache 2 2
Patient Problem/Medical Problem 2 2
Superficial (First Degree) Burn 2 2
Full thickness (Third Degree) Burn 1 1
Device Embedded In Tissue or Plaque 1 1
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 1 1
Hematoma 1 1
Inflammation 1 1
Pain 1 1
Bone Fracture(s) 1 1
Swelling 1 1
Skin Tears 1 1

Recalls
Manufacturer Recall Class Date Posted
1 GETINGE US SALES LLC II Mar-07-2019
2 GETINGE US SALES LLC II Apr-10-2018
3 GETINGE US SALES LLC II Mar-05-2018
4 Getinge Usa Sales Inc II Jun-30-2022
5 Stryker Communications II Mar-27-2020
6 Stryker Communications II Sep-12-2019
7 Stryker Communications II Aug-30-2019
8 Stryker Communications II May-21-2019
9 Stryker Communications II Mar-01-2018
10 Stryker Communications II Feb-23-2018
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