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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
2020 55 57
2021 54 54
2022 74 75
2023 74 74
2024 34 34
2025 62 62

Device Problems MDRs with this Device Problem Events in those MDRs
Break 219 219
Material Fragmentation 152 152
Fracture 123 123
Mechanical Problem 116 116
Detachment of Device or Device Component 38 39
Material Separation 12 14
Insufficient Information 7 7
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
Suction Problem 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
Difficult to Insert 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
Overheating of Device 1 1
Electrical /Electronic Property Problem 1 1
Gas Output Problem 1 1
Temperature Problem 1 1
Noise, Audible 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 197 198
Foreign Body In Patient 49 51
Insufficient Information 46 46
No Known Impact Or Consequence To Patient 26 26
Hemorrhage/Bleeding 13 13
No Consequences Or Impact To Patient 13 13
Device Embedded In Tissue or Plaque 5 5
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 3 3
Laceration(s) 3 3
Intraoperative Pain 2 2
Rupture 2 2
Burn(s) 2 2
Discomfort 2 2
Internal Organ Perforation 2 2
Abdominal Pain 1 1
Air Embolism 1 1
Dysuria 1 1
No Code Available 1 1
Gastrointestinal Hemorrhage 1 1
Unspecified Gastrointestinal Problem 1 1
Hematuria 1 1
Peritoneal Laceration(s) 1 1
Blood Loss 1 1
Cardiac Arrest 1 1
Thrombosis/Thrombus 1 1
No Patient Involvement 1 1
Unspecified Kidney or Urinary Problem 1 1

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