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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
KARL STORZ SE & CO. KG
  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 23 23

Device Problems MDRs with this Device Problem Events in those MDRs
Break 393 393
Material Fragmentation 234 234
Fracture 199 199
Mechanical Problem 190 190
Detachment of Device or Device Component 39 39
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
Noise, Audible 2 2
Loose or Intermittent Connection 2 2
Optical Obstruction 2 2
Suction Problem 2 2
Melted 2 2
Poor Quality Image 2 2
Device Dislodged or Dislocated 2 2
Device Operates Differently Than Expected 2 2
Bent 2 2
Device Contamination with Chemical or Other Material 2 2
Material Deformation 2 2
Thermal Decomposition of Device 2 2
Material Twisted/Bent 2 2
Moisture or Humidity Problem 2 2
Temperature Problem 1 1
Overheating of Device 1 1
Nonstandard Device 1 1
Optical Problem 1 1
Misassembly by Users 1 1
Device Handling Problem 1 1
Charred 1 1
Flare or Flash 1 1
Difficult to Remove 1 1
Microbial Contamination of Device 1 1
Device Emits Odor 1 1
Shelf Life Exceeded 1 1
Difficult to Insert 1 1
Device Markings/Labelling Problem 1 1
Suction Failure 1 1
Unintended Power Up 1 1
Material Opacification 1 1
Entrapment of Device 1 1
Migration or Expulsion of Device 1 1
No Display/Image 1 1
Sparking 1 1
Corroded 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 140 140
No Consequences Or Impact To Patient 68 68
Foreign Body In Patient 58 58
Insufficient Information 35 35
Device Embedded In Tissue or Plaque 34 34
Hemorrhage/Bleeding 15 15
No Information 8 8
No Code Available 6 6
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 3 3
Burn(s) 3 3
Injury 3 3
Discomfort 3 3
No Patient Involvement 3 3
Intraoperative Pain 2 2
Thrombus 2 2
Abdominal Pain 1 1
Air Embolism 1 1
Death 1 1
Complaint, Ill-Defined 1 1
Dysuria 1 1
Unspecified Gastrointestinal Problem 1 1
Hematuria 1 1
Perforation 1 1
Peritoneal Laceration(s) 1 1
Obstruction/Occlusion 1 1
Blood Loss 1 1
Multiple Organ Failure 1 1
Cardiac Arrest 1 1
Thrombosis/Thrombus 1 1
Swelling 1 1
Twitching 1 1
Laceration(s) 1 1
Unspecified Kidney or Urinary Problem 1 1
Bacterial Infection 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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