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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
2016 182 182
2017 161 161
2018 316 316
2019 444 444
2020 439 439
2021 116 116

Device Problems MDRs with this Device Problem Events in those MDRs
Detachment of Device or Device Component 474 474
Peeled/Delaminated 222 222
Crack 184 184
Break 151 151
Degraded 128 128
Component Falling 123 123
Material Integrity Problem 118 118
Flaked 104 104
Mechanical Problem 99 99
Corroded 91 91
Detachment Of Device Component 90 90
Material Fragmentation 78 78
Device Fell 68 68
Device Issue 37 37
Physical Property Issue 31 31
Material Separation 29 29
Component Missing 27 27
Device Operates Differently Than Expected 17 17
Temperature Problem 15 15
Grounding Malfunction 15 15
Loose or Intermittent Connection 15 15
Leak/Splash 14 14
Unintended Movement 14 14
Device Dislodged or Dislocated 12 12
Material Disintegration 12 12
Electrical /Electronic Property Problem 12 12
Use of Device Problem 12 12
Adverse Event Without Identified Device or Use Problem 11 11
Misassembled 10 10
Improper or Incorrect Procedure or Method 8 8
Smoking 7 7
Appropriate Term/Code Not Available 7 7
Device Slipped 6 6
Particulates 6 6
Device Maintenance Issue 6 6
Contamination 5 5
Burst Container or Vessel 5 5
Overheating of Device 5 5
Loss of Power 5 5
Split 5 5
Defective Device 5 5
Torn Material 5 5
Output Problem 5 5
Radiation Overexposure 5 5
Facilities Issue 5 5
Maintenance Does Not Comply To Manufacturers Recommendations 5 5
Radiation Output Problem 5 5
Misassembly During Maintenance/Repair 4 4
Device Contamination with Chemical or Other Material 4 4
Device Damaged by Another Device 4 4
Structural Problem 4 4
Contamination /Decontamination Problem 4 4
Failure to Power Up 3 3
Pitted 3 3
Unintended Collision 3 3
Fracture 3 3
Material Erosion 3 3
Inadequate Lighting 3 3
Material Deformation 3 3
Insufficient Information 3 3
Material Split, Cut or Torn 3 3
Material Distortion 2 2
Installation-Related Problem 2 2
Power Problem 2 2
Noise, Audible 2 2
Patient Device Interaction Problem 2 2
Component Misassembled 2 2
Device Emits Odor 2 2
Circuit Failure 2 2
Thermal Decomposition of Device 2 2
Unintended Arm Motion 2 2
Difficult To Position 2 2
Device Disinfection Or Sterilization Issue 2 2
Connection Problem 2 2
Contamination of Device Ingredient or Reagent 2 2
Sparking 2 2
Defective Component 2 2
Tear, Rip or Hole in Device Packaging 2 2
Cut In Material 1 1
Malposition of Device 1 1
Component or Accessory Incompatibility 1 1
Unintended System Motion 1 1
No Device Output 1 1
Metal Shedding Debris 1 1
Device Stops Intermittently 1 1
Device Inoperable 1 1
Unstable 1 1
Bent 1 1
Accessory Incompatible 1 1
Air Leak 1 1
Device Reprocessing Problem 1 1
Disassembly 1 1
Material Discolored 1 1
Disconnection 1 1
Nonstandard Device 1 1
Fire 1 1
Fluid Leak 1 1
Decoupling 1 1
Device Handling Problem 1 1
Misassembly by Users 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Known Impact Or Consequence To Patient 680 680
No Consequences Or Impact To Patient 634 634
No Patient Involvement 236 236
No Clinical Signs, Symptoms or Conditions 42 42
Injury 27 27
No Information 18 18
Burn(s) 9 9
Skin Discoloration 6 6
No Code Available 6 6
Laceration(s) 5 5
Burn, Thermal 3 3
Tissue Damage 3 3
Patient Problem/Medical Problem 2 2
Device Embedded In Tissue or Plaque 2 2
Bruise/Contusion 2 2
Head Injury 2 2
Erythema 2 2
Concussion 2 2
Superficial (First Degree) Burn 2 2
Skin Tears 1 1
Inflammation 1 1
Sprain 1 1
Swelling 1 1
Partial thickness (Second Degree) Burn 1 1
Muscle/Tendon Damage 1 1
Insufficient Information 1 1
Headache 1 1
Contusion 1 1
Bone Fracture(s) 1 1
Pain 1 1
Foreign Body In Patient 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Centurion Medical Products Corporation II Jul-20-2016
2 GETINGE US SALES LLC II Mar-07-2019
3 GETINGE US SALES LLC II Apr-10-2018
4 GETINGE US SALES LLC II Mar-05-2018
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
11 Stryker Communications II Mar-10-2017
12 Windstone Medical Packaging, Inc. II Apr-11-2017
13 Windstone Medical Packaging, Inc. II Feb-28-2017
14 Windstone Medical Packaging, Inc. II Oct-20-2016
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