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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device enteroscope and accessories
Regulation Description Endoscope and accessories.
Definition To provide visualization and perform various procedures within the small intestine. 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 CodeFDA
Regulation Number 876.1500
Device Class 2


Premarket Reviews
ManufacturerDecision
BODDINGTONS PLASTICS LTD
  SUBSTANTIALLY EQUIVALENT 1
FUJIFILM CORPORATION
  SUBSTANTIALLY EQUIVALENT 3

Device Problems
Adverse Event Without Identified Device or Use Problem 74
Appropriate Term/Code Not Available 43
Microbial Contamination of Device 8
Insufficient Information 6
Mechanical Problem 4
Device Reprocessing Problem 2
Balloon 2
Inflation Problem 2
Endoscopic Accessory 2
Endoscope 2
Display or Visual Feedback Problem 1
Connection Problem 1
No Apparent Adverse Event 1
Residue After Decontamination 1
Use of Device Problem 1
Misconnection 1
Device Operates Differently Than Expected 1
Device Contamination with Chemical or Other Material 1
Total Device Problems 153


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