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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device resectoscope
Regulation Description Endoscope and accessories.
Product CodeFJL
Regulation Number 876.1500
Device Class 2


Premarket Reviews
ManufacturerDecision
CORINTH MEDTECH, INC.
  SUBSTANTIALLY EQUIVALENT 1
KARL STORZ ENDOSCOPY AMERICA, INC.
  SUBSTANTIALLY EQUIVALENT 1
KARL STORZ SE & CO. KG
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2021 54 54
2022 74 75
2023 74 74
2024 34 34
2025 68 68
2026 10 10

Device Problems MDRs with this Device Problem Events in those MDRs
Break 183 183
Material Fragmentation 125 125
Fracture 92 92
Mechanical Problem 89 89
Detachment of Device or Device Component 37 38
Insufficient Information 11 11
Material Separation 10 10
Crack 6 6
Peeled/Delaminated 6 6
Adverse Event Without Identified Device or Use Problem 6 6
Entrapment of Device 4 4
Device Handling Problem 4 4
Poor Quality Image 3 3
Suction Failure 3 3
Material Twisted/Bent 3 3
Moisture or Humidity Problem 2 2
Material Deformation 2 2
Explosion 2 2
Optical Obstruction 2 2
Loose or Intermittent Connection 2 2
No Display/Image 1 1
Material Opacification 1 1
Unintended Power Up 1 1
Smoking 1 1
Component Missing 1 1
Thermal Decomposition of Device 1 1
Sharp Edges 1 1
Optical Problem 1 1
Misassembly by Users 1 1
Nonstandard Device 1 1
Overheating of Device 1 1
Electrical /Electronic Property Problem 1 1
Gas Output Problem 1 1
Loss of or Failure to Bond 1 1
Noise, Audible 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 203 204
Insufficient Information 47 47
Foreign Body In Patient 44 44
Hemorrhage/Bleeding 13 13
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 2 2
Intraoperative Pain 2 2
Rupture 2 2
Burn(s) 2 2
Discomfort 2 2
Laceration(s) 2 2
Erosion 2 2
Internal Organ Perforation 2 2
Device Embedded In Tissue or Plaque 2 2
Abdominal Pain 1 1
Air Embolism 1 1
Dysuria 1 1
Gastrointestinal Hemorrhage 1 1
Unspecified Gastrointestinal Problem 1 1
Hematuria 1 1
Peritoneal Laceration(s) 1 1
Cardiac Arrest 1 1
Thrombosis/Thrombus 1 1
Unspecified Kidney or Urinary Problem 1 1
No Consequences Or Impact To Patient 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Olympus Corporation of the Americas II Feb-20-2026
2 Olympus Corporation of the Americas II Dec-07-2022
3 Richard Wolf GmbH II Aug-12-2021
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