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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device mediastinoscope, surgical
Definition If the device is reusable, validated reprocessing instructions and reprocessing validation data for this device type must be included in a 510(k) submission (82 FR 26807, available at https://www.gpo.gov/fdsys/pkg/FR-2017-06-09/pdf/2017-12007.pdf).
Product CodeEWY
Regulation Number 874.4720
Device Class 2


Premarket Reviews
ManufacturerDecision
KARL STORZ ENDOSCOPY AMERICA, INC.
  SUBSTANTIALLY EQUIVALENT 2

MDR Year MDR Reports MDR Events
2021 4 4
2022 9 9
2023 97 97
2024 27 27

Device Problems MDRs with this Device Problem Events in those MDRs
Break 67 67
Detachment of Device or Device Component 22 22
Component Missing 9 9
Loose or Intermittent Connection 9 9
Crack 8 8
Mechanical Problem 5 5
Sharp Edges 5 5
Adverse Event Without Identified Device or Use Problem 4 4
Material Separation 3 3
Poor Quality Image 3 3
Defective Component 2 2
Material Deformation 2 2
Naturally Worn 2 2
Output Problem 2 2
Scratched Material 2 2
Device Handling Problem 1 1
Material Split, Cut or Torn 1 1
Material Integrity Problem 1 1
Optical Problem 1 1
Optical Obstruction 1 1
Microbial Contamination of Device 1 1
Connection Problem 1 1
Pitted 1 1
Degraded 1 1
Material Discolored 1 1
Disconnection 1 1
Material Fragmentation 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 128 128
Needle Stick/Puncture 4 4
Unspecified Respiratory Problem 3 3
Insufficient Information 1 1
Full thickness (Third Degree) Burn 1 1
Low Blood Pressure/ Hypotension 1 1

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