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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device choledochoscope and accessories, flexible/rigid
Definition to examine and perform procedures within the bile ducts. For reusable, flexible endoscopes in this product code, validated reprocessing instructions and reprocessing validation data must be included in a 510(k) submission (82 FR 26807, available at https://www.gpo.gov/fdsys/pkg/FR-2017-06-09/pdf/2017-12007.pdf).
Product CodeFBN
Regulation Number 876.1500
Device Class 2


Premarket Reviews
ManufacturerDecision
BOSTON SCIENTIFIC CORPORATION
  SUBSTANTIALLY EQUIVALENT 4
CENTERPOINT SYSTEMS LLC
  SUBSTANTIALLY EQUIVALENT 1
ENDOCURE TECHNOLOGIES, INC.
  SUBSTANTIALLY EQUIVALENT 1
MICRO-TECH (NANJING) CO., LTD
  SUBSTANTIALLY EQUIVALENT 1
OLYMPUS MEDICAL SYSTEMS CORP.
  SUBSTANTIALLY EQUIVALENT 1
OLYMPUS MEDICAL SYSTEMS CORPORATION
  SUBSTANTIALLY EQUIVALENT 1
SHANGHAI ANQING MEDICAL INSTRUMENT CO., LTD
  SUBSTANTIALLY EQUIVALENT 1
SHANGHAI SEEGEN PHOTOELECTRIC TECHNOLOGY CO., LTD
  SUBSTANTIALLY EQUIVALENT 1
SHENZHEN HUGEMED MEDICAL TECHNICAL DEVELOPMENT CO., LTD
  SUBSTANTIALLY EQUIVALENT 1
ZHUHAI PUSEN MEDICAL TECHNOLOGY CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2014 2 2
2015 2 2
2016 168 168
2017 224 224
2018 639 639
2019 105 105
2020 173 173
2021 158 158
2022 283 283
2023 105 105
2024 26 26

Device Problems MDRs with this Device Problem Events in those MDRs
Material Protrusion/Extrusion 1063 1063
Optical Problem 598 598
Appropriate Term/Code Not Available 320 320
Poor Quality Image 171 171
Device-Device Incompatibility 97 97
Adverse Event Without Identified Device or Use Problem 80 80
Difficult to Advance 43 43
Break 19 19
Insufficient Information 18 18
Peeled/Delaminated 16 16
Defective Device 15 15
Detachment Of Device Component 14 14
Connection Problem 10 10
Detachment of Device or Device Component 10 10
Mechanical Problem 7 7
No Display/Image 7 7
Material Integrity Problem 7 7
Positioning Problem 5 5
Microbial Contamination of Device 5 5
Contamination 4 4
Therapeutic or Diagnostic Output Failure 4 4
Unsealed Device Packaging 3 3
Difficult to Open or Close 3 3
Entrapment of Device 3 3
Leak/Splash 2 2
Loose or Intermittent Connection 2 2
Failure to Power Up 2 2
Difficult to Remove 2 2
Improper or Incorrect Procedure or Method 2 2
Material Split, Cut or Torn 2 2
Unexpected Shutdown 2 2
Device Contamination with Chemical or Other Material 1 1
Compatibility Problem 1 1
Material Deformation 1 1
Torn Material 1 1
Noise, Audible 1 1
Scratched Material 1 1
Output Problem 1 1
Fitting Problem 1 1
Material Perforation 1 1
Defective Component 1 1
Retraction Problem 1 1
Material Separation 1 1
Device Inoperable 1 1
Use of Device Problem 1 1
Tear, Rip or Hole in Device Packaging 1 1
Contamination /Decontamination Problem 1 1
Communication or Transmission Problem 1 1
Device Disinfection Or Sterilization Issue 1 1
Device Packaging Compromised 1 1
Electrical /Electronic Property Problem 1 1
Device Alarm System 1 1
Energy Output Problem 1 1
Fluid/Blood Leak 1 1
Fracture 1 1
Material Fragmentation 1 1
Image Display Error/Artifact 1 1
Device Reprocessing Problem 1 1
Collapse 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Consequences Or Impact To Patient 1197 1197
No Clinical Signs, Symptoms or Conditions 536 536
No Known Impact Or Consequence To Patient 58 58
Injury 19 19
Inflammation 18 18
Perforation 16 16
Hemorrhage/Bleeding 15 15
Pancreatitis 8 8
No Patient Involvement 7 7
No Code Available 6 6
Unspecified Respiratory Problem 6 6
Insufficient Information 6 6
Laceration(s) 5 5
Unspecified Infection 4 4
Fever 3 3
Fistula 3 3
Pain 3 3
Sepsis 3 3
Pneumonia 2 2
Air Embolism 2 2
Death 2 2
Unspecified Hepatic or Biliary Problem 2 2
No Information 2 2
Abrasion 1 1
Device Embedded In Tissue or Plaque 1 1
Foreign Body In Patient 1 1
Patient Problem/Medical Problem 1 1
Ascites 1 1
Gastrointestinal Hemorrhage 1 1
Liver Failure 1 1
Dyspnea 1 1
Cardiac Arrest 1 1
Pneumothorax 1 1
Tissue Damage 1 1
Peritonitis 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Aizu Olympus Co., Ltd. II Nov-17-2023
2 Boston Scientific Corporation II Mar-19-2018
3 Olympus Corporation of the Americas II May-20-2022
4 Olympus Corporation of the Americas II Oct-16-2020
5 Olympus Corporation of the Americas II Feb-24-2017
6 Pentax Medical Company II Jun-28-2016
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