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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device lamp, surgical
Product CodeFTD
Regulation Number 878.4580
Device Class 2

MDR Year MDR Reports MDR Events
2017 10 10
2018 16 16
2019 80 80
2020 105 105
2021 65 65
2022 35 35

Device Problems MDRs with this Device Problem Events in those MDRs
Detachment of Device or Device Component 125 125
Adverse Event Without Identified Device or Use Problem 72 72
Crack 32 32
Peeled/Delaminated 32 32
Corroded 29 29
Device Fell 12 12
Break 12 12
Disconnection 6 6
Improper or Incorrect Procedure or Method 4 4
Device Operational Issue 4 4
Appropriate Term/Code Not Available 3 3
Temperature Problem 3 3
Detachment Of Device Component 3 3
Fracture 3 3
Component Falling 2 2
Material Erosion 2 2
Device Handling Problem 2 2
Unintended Collision 2 2
Material Integrity Problem 2 2
Fluid Leak 2 2
Sparking 1 1
Device Contamination with Chemical or Other Material 1 1
Sharp Edges 1 1
Excessive Heating 1 1
Misassembly During Maintenance/Repair 1 1
Insufficient Information 1 1
Output Problem 1 1
Device Expiration Issue 1 1
Flaked 1 1
Electrical /Electronic Property Problem 1 1
Contamination 1 1
Intermittent Continuity 1 1
Grounding Malfunction 1 1
Loose or Intermittent Connection 1 1
Moisture Damage 1 1
Pitted 1 1
Failure to Power Up 1 1
Off-Label Use 1 1
Device Slipped 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Consequences Or Impact To Patient 105 105
No Clinical Signs, Symptoms or Conditions 86 86
Irritation 25 25
Pain 19 19
No Known Impact Or Consequence To Patient 17 17
Perforation 11 11
No Code Available 7 7
No Patient Involvement 4 4
Radiation Exposure, Unintended 4 4
No Information 4 4
Injury 3 3
Numbness 2 2
Post Operative Wound Infection 2 2
Atrial Perforation 2 2
Cardiac Perforation 2 2
Burn(s) 2 2
Stroke/CVA 2 2
Hemorrhage/Bleeding 2 2
Brain Injury 2 2
Scarring 2 2
Perforation of Vessels 2 2
Great Vessel Perforation 1 1
Scar Tissue 1 1
Discomfort 1 1
Insufficient Information 1 1
Abrasion 1 1
Death 1 1
Laceration(s) 1 1
Muscle Weakness 1 1
Nerve Damage 1 1
Skin Tears 1 1
Burn, Thermal 1 1
Blood Loss 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Maquet Cardiovascular Us Sales, Llc II Jun-21-2019
2 Maquet SAS II Jul-19-2018
3 Maquet SAS II May-25-2018
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