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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 19 19

Device Problems MDRs with this Device Problem Events in those MDRs
Break 163 163
Material Fragmentation 121 121
Fracture 92 92
Mechanical Problem 89 89
Detachment of Device or Device Component 30 31
Insufficient Device Problem Information 11 11
Material Separation 9 9
Adverse Event Without Identified Device or Use Problem 6 6
Peeled/Delaminated 6 6
Crack 5 5
Optical Obstruction 4 4
Device Handling Problem 4 4
Suction Failure 3 3
Poor Quality Image 3 3
Explosion 2 2
Moisture or Humidity Problem 2 2
Material Twisted/Bent 2 2
Material Deformation 2 2
Loose or Intermittent Connection 2 2
Loss of or Failure to Bond 1 1
Misassembly by Users 1 1
Electrical /Electronic Property Problem 1 1
Overheating of Device 1 1
No Display/Image 1 1
Optical Problem 1 1
Unintended Power Up 1 1
Sharp Edges 1 1
Gas Output Problem 1 1
Material Opacification 1 1
Mechanical Jam 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 208 209
Insufficient Information 51 51
Foreign Body In Patient 45 45
Hemorrhage/Blood Loss/Bleeding 13 13
Laceration(s) 2 2
Device Embedded In Tissue or Plaque 2 2
Burn(s) 2 2
Erosion 2 2
Internal Organ Perforation 2 2
Rupture 2 2
Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available 2 2
Discomfort 2 2
Intraoperative Pain 2 2
No Consequences Or Impact To Patient 1 1
Peritoneal Laceration(s) 1 1
Thrombosis/Thrombus 1 1
Hematuria 1 1
Unspecified Kidney or Urinary Problem 1 1
Dysuria 1 1
Abdominal Pain 1 1
Cardiac Arrest 1 1
Gastrointestinal Hemorrhage 1 1
Air Embolism 1 1
Unspecified Gastrointestinal Problem 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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