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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device laryngoscope, endoscope
Regulation Description Endoscope and accessories.
Product CodeGCI
Regulation Number 876.1500
Device Class 2

Device Problems
Material Split, Cut or Torn 147
Torn Material 129
Break 78
Detachment of Device or device Component 75
Detachment Of Device Component 60
Material Separation 40
Optical Problem 13
Material Rupture 12
Failure to Conduct 8
Adverse Event Without Identified Device or Use Problem 7
Difficult to Remove 7
Bags 7
Difficult to Open or Close 5
Charging Problem 5
Difficult to Insert 4
Material Fragmentation 3
Hole In Material 3
Bent 3
Positioning Problem 2
Mechanical Problem 2
Material Perforation 2
Component Missing 2
Burst Container or Vessel 2
Difficult or Delayed Positioning 2
Failure to Charge 1
Device Damaged Prior to Use 1
Poor Quality Image 1
Device Packaging Compromised 1
Device Difficult to Maintain 1
Loose or Intermittent Connection 1
Appropriate Term/Code Not Available 1
Mechanics Altered 1
Improper or Incorrect Procedure or Method 1
Device Contamination with Chemical or Other Material 1
Insufficient Information 1
Material Puncture / Hole 1
Ring 1
Out-Of-Box Failure 1
Crack 1
Device Or Device Fragments Location Unknown 1
Use of Device Problem 1
Environmental Particulates 1
Material Deformation 1
Patient Device Interaction Problem 1
Product Quality Problem 1
Total Device Problems 639

Recalls
Manufacturer Recall Class Date Posted
1 Covidien Llc II Jun-03-2020
2 EXP Pharmaceutical Services Corp II Jul-24-2015

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