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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 55
2021 54 54
2022 74 74
2023 75 75
2024 34 34
2025 37 37

Device Problems MDRs with this Device Problem Events in those MDRs
Break 206 206
Material Fragmentation 149 149
Fracture 123 123
Mechanical Problem 116 116
Detachment of Device or Device Component 31 31
Material Separation 12 12
Insufficient Information 8 8
Crack 6 6
Peeled/Delaminated 6 6
Adverse Event Without Identified Device or Use Problem 6 6
Device Handling Problem 4 4
Entrapment of Device 3 3
Poor Quality Image 3 3
Material Twisted/Bent 2 2
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
Suction Failure 1 1
Smoking 1 1
Difficult to Insert 1 1
Component Missing 1 1
Thermal Decomposition of Device 1 1
Optical Problem 1 1
Misassembly by Users 1 1
Overheating of Device 1 1
Electrical /Electronic Property 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 179 179
Foreign Body In Patient 45 45
Insufficient Information 44 44
No Known Impact Or Consequence To Patient 26 26
No Consequences Or Impact To Patient 13 13
Hemorrhage/Bleeding 13 13
Device Embedded In Tissue or Plaque 4 4
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 3 3
Burn(s) 3 3
Intraoperative Pain 2 2
Rupture 2 2
Discomfort 2 2
Laceration(s) 2 2
Internal Organ Perforation 2 2
Air Embolism 1 1
Abdominal Pain 1 1
No Code Available 1 1
Dysuria 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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