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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
Regulation Description Endoscope and accessories.
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 1
CENTERPOINT SYSTEMS LLC
  SUBSTANTIALLY EQUIVALENT 1
MICRO-TECH (NANJING) CO., LTD
  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
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
2020 173 173
2021 158 158
2022 283 283
2023 105 105
2024 107 107
2025 4 4

Device Problems MDRs with this Device Problem Events in those MDRs
Optical Problem 616 616
Appropriate Term/Code Not Available 314 314
Poor Quality Image 167 167
Device-Device Incompatibility 98 98
Adverse Event Without Identified Device or Use Problem 84 84
Difficult to Advance 32 32
Peeled/Delaminated 17 17
Break 14 14
Connection Problem 12 12
Defective Device 11 11
Device Reprocessing Problem 9 9
Mechanical Problem 7 7
Material Integrity Problem 5 5
Detachment of Device or Device Component 5 5
Positioning Problem 4 4
Therapeutic or Diagnostic Output Failure 4 4
Difficult to Open or Close 3 3
Unexpected Shutdown 2 2
Loose or Intermittent Connection 2 2
Contamination 2 2
No Display/Image 2 2
Failure to Power Up 2 2
Material Split, Cut or Torn 2 2
Material Deformation 2 2
Improper or Incorrect Procedure or Method 2 2
Scratched Material 1 1
Unsealed Device Packaging 1 1
Noise, Audible 1 1
Energy Output Problem 1 1
Entrapment of Device 1 1
Communication or Transmission Problem 1 1
Microbial Contamination of Device 1 1
Image Display Error/Artifact 1 1
Device Alarm System 1 1
Fitting Problem 1 1
Fluid/Blood Leak 1 1
Tear, Rip or Hole in Device Packaging 1 1
Output Problem 1 1
Compatibility Problem 1 1
Device Contamination with Chemical or Other Material 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 612 612
No Consequences Or Impact To Patient 172 172
Perforation 11 11
Pancreatitis 9 9
Insufficient Information 8 8
Inflammation 6 6
Unspecified Respiratory Problem 6 6
Hemorrhage/Bleeding 5 5
No Code Available 5 5
Sepsis 4 4
Fever 3 3
Fistula 3 3
No Known Impact Or Consequence To Patient 3 3
Air Embolism 2 2
Cardiac Arrest 2 2
Pain 2 2
Pneumonia 2 2
Unspecified Hepatic or Biliary Problem 2 2
Bacterial Infection 1 1
Death 1 1
Dyspnea 1 1
Unspecified Infection 1 1
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 1 1
Pneumothorax 1 1
Septic Shock 1 1
Ascites 1 1
Gastrointestinal Hemorrhage 1 1
Liver Failure 1 1
Peritonitis 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Aizu Olympus Co., Ltd. II Nov-17-2023
2 Olympus Corporation of the Americas I Jan-16-2025
3 Olympus Corporation of the Americas II May-20-2022
4 Olympus Corporation of the Americas II Oct-16-2020
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