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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device camera, television, surgical, without audio
Regulation Description Surgical camera and accessories.
Product CodeFWB
Regulation Number 878.4160
Device Class 1

MDR Year MDR Reports MDR Events
2016 11 11
2017 3 3
2018 4 4
2019 4 4
2020 13 13

Device Problems MDRs with this Device Problem Events in those MDRs
No Display/Image 19 19
Output Problem 12 12
Device Operates Differently Than Expected 4 4
Monitor 4 4
Image Display Error/Artifact 2 2
Power Problem 2 2
Loss of Power 2 2
Power Supply 2 2
Self-Activation or Keying 1 1
Inappropriate/Inadequate Shock/Stimulation 1 1
Smoking 1 1
Device Inoperable 1 1
Noise, Audible 1 1
Adverse Event Without Identified Device or Use Problem 1 1
Optical Problem 1 1
Melted 1 1
Device Emits Odor 1 1
Unintended Collision 1 1
Break 1 1
Component Falling 1 1
Display Difficult to Read 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Known Impact Or Consequence To Patient 31 31
No Consequences Or Impact To Patient 11 11
Injury 2 2
No Patient Involvement 1 1
No Code Available 1 1
No Clinical Signs, Symptoms or Conditions 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Trumpf Medical Systems, Inc. II Mar-01-2018
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