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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 4
KARL STORZ ENDOSCOPY AMERICA, INC
  SUBSTANTIALLY EQUIVALENT 1
NATIONAL ADVANCED ENDOSCOPY DEVICES, INC.
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2014 36 36
2015 45 45
2016 25 25
2017 28 28
2018 50 50
2019 53 53
2020 55 55
2021 54 54
2022 74 74
2023 75 75
2024 8 8

Device Problems MDRs with this Device Problem Events in those MDRs
Break 390 390
Material Fragmentation 231 231
Fracture 199 199
Mechanical Problem 190 190
Detachment of Device or Device Component 38 38
Detachment Of Device Component 27 27
Component Falling 17 17
Material Separation 12 12
Crack 8 8
Adverse Event Without Identified Device or Use Problem 8 8
Insufficient Information 6 6
Component Missing 4 4
Smoking 3 3
Improper or Incorrect Procedure or Method 2 2
Suction Problem 2 2
Bent 2 2
Device Operates Differently Than Expected 2 2
Device Dislodged or Dislocated 2 2
Thermal Decomposition of Device 2 2
Melted 2 2
Noise, Audible 2 2
Moisture or Humidity Problem 2 2
Optical Obstruction 2 2
Device Contamination with Chemical or Other Material 2 2
Material Deformation 2 2
Material Twisted/Bent 1 1
Mechanical Jam 1 1
Temperature Problem 1 1
Optical Problem 1 1
Suction Failure 1 1
Device Handling Problem 1 1
Migration or Expulsion of Device 1 1
Poor Quality Image 1 1
Nonstandard Device 1 1
Device Emits Odor 1 1
Overheating of Device 1 1
Difficult to Remove 1 1
Charred 1 1
Corroded 1 1
Unintended Power Up 1 1
No Display/Image 1 1
Electrical /Electronic Property Problem 1 1
Entrapment of Device 1 1
Flaked 1 1
Flare or Flash 1 1
Device Markings/Labelling Problem 1 1
Sparking 1 1
Shelf Life Exceeded 1 1
Difficult to Insert 1 1
Loose or Intermittent Connection 1 1
Microbial Contamination of Device 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 142 142
No Known Impact Or Consequence To Patient 140 140
No Consequences Or Impact To Patient 68 68
Foreign Body In Patient 57 57
Device Embedded In Tissue or Plaque 34 34
Insufficient Information 31 31
Hemorrhage/Bleeding 15 15
No Information 8 8
No Code Available 6 6
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 3 3
No Patient Involvement 3 3
Burn(s) 3 3
Discomfort 3 3
Injury 3 3
Thrombus 2 2
Intraoperative Pain 2 2
Dysuria 1 1
Multiple Organ Failure 1 1
Thrombosis/Thrombus 1 1
Unspecified Gastrointestinal Problem 1 1
Twitching 1 1
Complaint, Ill-Defined 1 1
Obstruction/Occlusion 1 1
Hematuria 1 1
Blood Loss 1 1
Cardiac Arrest 1 1
Death 1 1
Abdominal Pain 1 1
Air Embolism 1 1
Bacterial Infection 1 1
Laceration(s) 1 1
Perforation 1 1
Peritoneal Laceration(s) 1 1
Swelling 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Karl Storz Endoscopy America Inc II May-11-2013
2 Olympus Corporation of the Americas II Dec-07-2022
3 Richard Wolf GmbH II Aug-12-2021
4 Richard Wolf Medical Instruments Corp. II Nov-04-2013
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