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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
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

MDR Year MDR Reports MDR Events
2017 28 28
2018 81 81
2019 76 76
2020 29 29
2021 24 24
2022 38 38

Device Problems MDRs with this Device Problem Events in those MDRs
Adverse Event Without Identified Device or Use Problem 141 141
Appropriate Term/Code Not Available 43 43
Insufficient Information 30 30
Microbial Contamination of Device 16 16
Device Operates Differently Than Expected 9 9
Corroded 4 4
Crack 4 4
Mechanical Problem 3 3
Patient-Device Incompatibility 3 3
Contamination /Decontamination Problem 3 3
Misassembly by Users 2 2
Failure to Deflate 2 2
Device Sensing Problem 2 2
Increase in Pressure 2 2
Failure to Calibrate 2 2
Partial Blockage 2 2
Break 2 2
Fluid Leak 2 2
Inflation Problem 2 2
Leak/Splash 2 2
Device Reprocessing Problem 1 1
Deflation Problem 1 1
Display or Visual Feedback Problem 1 1
Physical Resistance 1 1
Residue After Decontamination 1 1
Overfill 1 1
Use of Device Problem 1 1
Difficult To Position 1 1
Failure of Device to Self-Test 1 1
Device Contamination with Chemical or Other Material 1 1
Output Problem 1 1
Positioning Problem 1 1
Protective Measures Problem 1 1
Failure to Clean Adequately 1 1
No Apparent Adverse Event 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
Inflammation 61 61
Perforation 61 61
No Code Available 38 38
Not Applicable 28 28
Pneumonia 20 20
Injury 16 16
No Clinical Signs, Symptoms or Conditions 14 14
Laceration(s) 12 12
Unspecified Infection 10 10
Abdominal Pain 9 9
Bowel Perforation 9 9
No Known Impact Or Consequence To Patient 8 8
Hemorrhage/Bleeding 8 8
No Patient Involvement 8 8
No Consequences Or Impact To Patient 8 8
Ischemia 6 6
Laceration(s) of Esophagus 6 6
Pancreatitis 6 6
Cancer 5 5
Blood Loss 5 5
Abscess 5 5
Bradycardia 5 5
Hypoxia 4 4
Death 3 3
Abrasion 3 3
Internal Organ Perforation 3 3
Nausea 2 2
Abdominal Distention 2 2
Aspiration/Inhalation 2 2
Hyperglycemia 2 2
High Blood Pressure/ Hypertension 2 2
Dyspnea 2 2
Gastrointestinal Hemorrhage 2 2
Unspecified Tissue Injury 2 2
Insufficient Information 2 2
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 1 1
Stomach Ulceration 1 1
Unspecified Gastrointestinal Problem 1 1
Melena 1 1
Aspiration Pneumonitis 1 1
Patient Problem/Medical Problem 1 1
Liver Damage/Dysfunction 1 1
Irritation 1 1
Low Blood Pressure/ Hypotension 1 1
Bronchospasm 1 1
Perforation of Esophagus 1 1
Low Oxygen Saturation 1 1
Respiratory Failure 1 1
Pain 1 1
Stenosis 1 1
Ulcer 1 1

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