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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device resectoscope
Product CodeFJL
Regulation Number 876.1500
Device Class 2


Premarket Reviews
ManufacturerDecision
CORINTH MEDTECH, INC.
  SUBSTANTIALLY EQUIVALENT 3
KARL STORZ ENDOSCOPY AMERICA, INC
  SUBSTANTIALLY EQUIVALENT 1
KARL STORZ SE & CO. KG
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2019 53 53
2020 55 55
2021 54 54
2022 74 74
2023 75 75
2024 23 23

Device Problems MDRs with this Device Problem Events in those MDRs
Break 239 239
Material Fragmentation 180 180
Fracture 159 159
Mechanical Problem 151 151
Detachment of Device or Device Component 29 29
Material Separation 12 12
Crack 6 6
Insufficient Information 6 6
Adverse Event Without Identified Device or Use Problem 6 6
Suction Problem 2 2
Loose or Intermittent Connection 2 2
Poor Quality Image 2 2
Moisture or Humidity Problem 2 2
Material Deformation 2 2
Material Twisted/Bent 2 2
Optical Obstruction 2 2
Entrapment of Device 1 1
No Display/Image 1 1
Material Opacification 1 1
Difficult to Insert 1 1
Mechanical Jam 1 1
Electrical /Electronic Property Problem 1 1
Noise, Audible 1 1
Temperature Problem 1 1
Suction Failure 1 1
Unintended Power Up 1 1
Smoking 1 1
Thermal Decomposition of Device 1 1
Misassembly by Users 1 1
Optical Problem 1 1
Component Missing 1 1
Overheating of Device 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 151 151
No Known Impact Or Consequence To Patient 66 66
Foreign Body In Patient 38 38
Insufficient Information 35 35
No Consequences Or Impact To Patient 18 18
Hemorrhage/Bleeding 13 13
Device Embedded In Tissue or Plaque 11 11
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 3 3
Burn(s) 3 3
Discomfort 3 3
Intraoperative Pain 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
Laceration(s) 1 1
Unspecified Kidney or Urinary Problem 1 1
Thrombus 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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