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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 2
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
ZHUHAI PUSEN MEDICAL TECHNOLOGY CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2019 105 105
2020 173 173
2021 158 158
2022 283 283
2023 105 105
2024 64 64

Device Problems MDRs with this Device Problem Events in those MDRs
Optical Problem 594 594
Appropriate Term/Code Not Available 314 314
Poor Quality Image 165 165
Device-Device Incompatibility 96 96
Adverse Event Without Identified Device or Use Problem 80 80
Material Protrusion/Extrusion 72 72
Difficult to Advance 32 32
Insufficient Information 18 18
Peeled/Delaminated 16 16
Break 14 14
Defective Device 12 12
Connection Problem 11 11
Detachment of Device or Device Component 7 7
Mechanical Problem 7 7
Material Integrity Problem 7 7
No Display/Image 6 6
Therapeutic or Diagnostic Output Failure 4 4
Positioning Problem 4 4
Difficult to Open or Close 3 3
Contamination 3 3
Unsealed Device Packaging 3 3
Microbial Contamination of Device 2 2
Failure to Power Up 2 2
Entrapment of Device 2 2
Unexpected Shutdown 2 2
Material Split, Cut or Torn 2 2
Loose or Intermittent Connection 2 2
Improper or Incorrect Procedure or Method 2 2
Energy Output Problem 1 1
Image Display Error/Artifact 1 1
Device Alarm System 1 1
Scratched Material 1 1
Output Problem 1 1
Communication or Transmission Problem 1 1
Material Deformation 1 1
Tear, Rip or Hole in Device Packaging 1 1
Device Contamination with Chemical or Other Material 1 1
Compatibility Problem 1 1
Fitting Problem 1 1
Electrical /Electronic Property Problem 1 1
Fluid/Blood Leak 1 1
Noise, Audible 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 569 569
No Consequences Or Impact To Patient 241 241
Injury 18 18
No Known Impact Or Consequence To Patient 13 13
Perforation 11 11
Inflammation 10 10
Pancreatitis 8 8
Insufficient Information 8 8
Unspecified Respiratory Problem 6 6
No Code Available 5 5
Hemorrhage/Bleeding 5 5
Sepsis 4 4
Fever 3 3
Fistula 3 3
Air Embolism 2 2
Cardiac Arrest 2 2
Laceration(s) 2 2
Pain 2 2
Unspecified Hepatic or Biliary Problem 2 2
Pneumonia 2 2
Unspecified Infection 1 1
Liver Failure 1 1
Death 1 1
Pneumothorax 1 1
Gastrointestinal Hemorrhage 1 1
Peritonitis 1 1
Septic Shock 1 1
No Patient Involvement 1 1
Dyspnea 1 1
Ascites 1 1

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