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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 10 10

Device Problems MDRs with this Device Problem Events in those MDRs
Break 236 236
Material Fragmentation 179 179
Fracture 159 159
Mechanical Problem 151 151
Detachment of Device or Device Component 28 28
Material Separation 12 12
Crack 6 6
Adverse Event Without Identified Device or Use Problem 6 6
Insufficient Information 6 6
Optical Obstruction 2 2
Moisture or Humidity Problem 2 2
Suction Problem 2 2
Material Deformation 2 2
Material Twisted/Bent 1 1
Mechanical Jam 1 1
Smoking 1 1
Poor Quality Image 1 1
Overheating of Device 1 1
Unintended Power Up 1 1
No Display/Image 1 1
Electrical /Electronic Property Problem 1 1
Entrapment of Device 1 1
Difficult to Insert 1 1
Loose or Intermittent Connection 1 1
Thermal Decomposition of Device 1 1
Component Missing 1 1
Temperature Problem 1 1
Optical Problem 1 1
Noise, Audible 1 1
Suction Failure 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 144 144
No Known Impact Or Consequence To Patient 66 66
Foreign Body In Patient 37 37
Insufficient Information 31 31
No Consequences Or Impact To Patient 18 18
Hemorrhage/Bleeding 13 13
Device Embedded In Tissue or Plaque 11 11
Discomfort 3 3
Burn(s) 3 3
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 3 3
Intraoperative Pain 2 2
Dysuria 1 1
Cardiac Arrest 1 1
Abdominal Pain 1 1
Air Embolism 1 1
Laceration(s) 1 1
Peritoneal Laceration(s) 1 1
Thrombus 1 1
Hematuria 1 1
Blood Loss 1 1
No Patient Involvement 1 1
No Code Available 1 1
Thrombosis/Thrombus 1 1
Unspecified Gastrointestinal 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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