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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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New Search show TPLC since Back to Search Results
Device endoilluminator
Regulation Description Endoscope and accessories.
Product CodeMPA
Regulation Number 876.1500
Device Class 2


Premarket Reviews
ManufacturerDecision
PEREGRINE SURGICAL LTD.
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2015 4 4
2016 2 2
2017 2 2
2018 4 4

Device Problems MDRs with this Device Problem Events in those MDRs
Device Operates Differently Than Expected 3 3
Loss of Power 2 2
Break 2 2
Material Fragmentation 1 1
Material Separation 1 1
Component Missing 1 1
Device Or Device Fragments Location Unknown 1 1
Light Interference 1 1
Physical Property Issue 1 1
Insufficient Information 1 1
Bag 1 1
Electrical /Electronic Property Problem 1 1
Leak/Splash 1 1
Adverse Event Without Identified Device or Use Problem 1 1
Fiberoptic 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Consequences Or Impact To Patient 7 7
Foreign Body In Patient 2 2
Endophthalmitis 1 1
Visual Impairment 1 1
No Patient Involvement 1 1
No Known Impact Or Consequence To Patient 1 1

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