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TPLC
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Device
light, surgical, accessories
Regulation Description
Surgical lamp.
Product Code
FTA
Regulation Number
878.4580
Device Class
2
MDR Year
MDR Reports
MDR Events
2020
18
18
2021
20
20
2022
14
14
2023
105
105
2024
29
29
2025
1
1
Device Problems
MDRs with this Device Problem
Events in those MDRs
Detachment of Device or Device Component
114
114
Crack
20
20
Device Fell
15
15
Display or Visual Feedback Problem
7
7
Unsealed Device Packaging
7
7
Contamination
5
5
Contamination /Decontamination Problem
3
3
Component Missing
3
3
Peeled/Delaminated
2
2
Delivered as Unsterile Product
2
2
Product Quality Problem
2
2
Material Puncture/Hole
2
2
Flaked
2
2
No Apparent Adverse Event
2
2
Break
2
2
No Display/Image
2
2
Intermittent Loss of Power
1
1
Mechanics Altered
1
1
Corroded
1
1
Structural Problem
1
1
Device Emits Odor
1
1
Electrical /Electronic Property Problem
1
1
Device Contamination with Chemical or Other Material
1
1
Material Split, Cut or Torn
1
1
Mechanical Jam
1
1
Defective Device
1
1
Device Contaminated During Manufacture or Shipping
1
1
Insufficient Information
1
1
Tear, Rip or Hole in Device Packaging
1
1
Separation Problem
1
1
Device Contaminated at the User Facility
1
1
Use of Device Problem
1
1
Defective Component
1
1
Smoking
1
1
Image Display Error/Artifact
1
1
Output Problem
1
1
Patient Problems
MDRs with this Patient Problem
Events in those MDRs
No Clinical Signs, Symptoms or Conditions
157
157
Insufficient Information
19
19
No Known Impact Or Consequence To Patient
9
9
Unspecified Infection
1
1
No Consequences Or Impact To Patient
1
1
Recalls
Manufacturer
Recall Class
Date Posted
1
Steris Corporation
II
Apr-28-2023
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