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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 40 40

Device Problems MDRs with this Device Problem Events in those MDRs
Optical Problem 579 579
Appropriate Term/Code Not Available 314 314
Poor Quality Image 162 162
Device-Device Incompatibility 92 92
Adverse Event Without Identified Device or Use Problem 73 73
Material Protrusion/Extrusion 72 72
Difficult to Advance 31 31
Insufficient Information 18 18
Peeled/Delaminated 16 16
Break 14 14
Defective Device 12 12
Connection Problem 9 9
Material Integrity Problem 7 7
Mechanical Problem 7 7
No Display/Image 6 6
Detachment of Device or Device Component 6 6
Positioning Problem 4 4
Therapeutic or Diagnostic Output Failure 4 4
Difficult to Open or Close 3 3
Contamination 3 3
Unsealed Device Packaging 3 3
Failure to Power Up 2 2
Improper or Incorrect Procedure or Method 2 2
Entrapment of Device 2 2
Loose or Intermittent Connection 2 2
Microbial Contamination of Device 2 2
Material Split, Cut or Torn 2 2
Unexpected Shutdown 2 2
Noise, Audible 1 1
Tear, Rip or Hole in Device Packaging 1 1
Communication or Transmission Problem 1 1
Device Contamination with Chemical or Other Material 1 1
Compatibility Problem 1 1
Scratched Material 1 1
Output Problem 1 1
Device Alarm System 1 1
Fluid/Blood Leak 1 1
Image Display Error/Artifact 1 1
Electrical /Electronic Property Problem 1 1
Fitting Problem 1 1
Energy Output Problem 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 549 549
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 6 6
Unspecified Respiratory Problem 6 6
No Code Available 5 5
Hemorrhage/Bleeding 5 5
Sepsis 4 4
Fever 3 3
Fistula 3 3
Laceration(s) 2 2
Pain 2 2
Pneumonia 2 2
Unspecified Hepatic or Biliary Problem 2 2
Liver Failure 1 1
Gastrointestinal Hemorrhage 1 1
Pneumothorax 1 1
Septic Shock 1 1
Ascites 1 1
No Patient Involvement 1 1
Peritonitis 1 1
Unspecified Infection 1 1
Air Embolism 1 1
Death 1 1
Dyspnea 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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