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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 2

MDR Year MDR Reports MDR Events
2016 5 5
2017 28 28
2018 81 81
2019 76 76
2020 29 29
2021 12 12

Device Problems MDRs with this Device Problem Events in those MDRs
Adverse Event Without Identified Device or Use Problem 105 105
Appropriate Term/Code Not Available 43 43
Insufficient Information 30 30
Microbial Contamination of Device 10 10
Device Operates Differently Than Expected 10 10
Crack 4 4
Inflation Problem 4 4
Mechanical Problem 4 4
Corroded 4 4
Patient-Device Incompatibility 3 3
Failure to Deflate 2 2
Break 2 2
Device Reprocessing Problem 2 2
Failure to Calibrate 2 2
Leak/Splash 2 2
Device Sensing Problem 2 2
Increase in Pressure 2 2
Device Contamination with Chemical or Other Material 2 2
Residue After Decontamination 1 1
Contamination /Decontamination Problem 1 1
Connection Problem 1 1
Failure of Device to Self-Test 1 1
Misconnection 1 1
Physical Resistance 1 1
Overfill 1 1
Protective Measures Problem 1 1
Misassembly by Users 1 1
No Apparent Adverse Event 1 1
Deflation Problem 1 1
Display or Visual Feedback Problem 1 1
Difficult To Position 1 1
Use of Device Problem 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
Inflammation 60 60
Perforation 54 54
No Code Available 38 38
Not Applicable 28 28
Pneumonia 20 20
Injury 16 16
Unspecified Infection 10 10
No Consequences Or Impact To Patient 10 10
Bowel Perforation 9 9
No Patient Involvement 9 9
Laceration(s) 8 8
No Known Impact Or Consequence To Patient 8 8
Cancer 5 5
Abscess 5 5
Blood Loss 5 5
Internal Organ Perforation 3 3
Abdominal Pain 3 3
Death 3 3
Ischemia 3 3
Insufficient Information 2 2
No Clinical Signs, Symptoms or Conditions 2 2
Aspiration/Inhalation 2 2
Gastrointestinal Hemorrhage 2 2
Unspecified Tissue Injury 1 1
Patient Problem/Medical Problem 1 1
Flatus 1 1
Irritation 1 1
Perforation of Esophagus 1 1
Respiratory Failure 1 1
Melena 1 1

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