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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device duodenoscope and accessories, flexible/rigid
Definition To examine the duodenum and to perform various procedures within the duodenum. If the device is reusable, validated reprocessing instructions and reprocessing validation data for this device type 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 CodeFDT
Regulation Number 876.1500
Device Class 2


Premarket Reviews
ManufacturerDecision
AMBU A/S
  SUBSTANTIALLY EQUIVALENT 1
AMBU INNOVATION GMBH
  SUBSTANTIALLY EQUIVALENT 1
BOSTON SCIENTIFIC CORPORATION
  SUBSTANTIALLY EQUIVALENT 1
FUJIFILM CORPORATION
  SUBSTANTIALLY EQUIVALENT 3
OLYMPUS MEDICAL SYSTEMS CORP.
  SUBSTANTIALLY EQUIVALENT 3
PENTAX MEDICAL
  SUBSTANTIALLY EQUIVALENT 1
PENTAX OF AMERICA, INC.
  SUBSTANTIALLY EQUIVALENT 3

MDR Year MDR Reports MDR Events
2019 1347 1347
2020 822 822
2021 1270 1270
2022 2619 2619
2023 3050 3050
2024 1006 1006

Device Problems MDRs with this Device Problem Events in those MDRs
Failure to Clean Adequately 1758 1758
Microbial Contamination of Device 1210 1210
Break 1112 1112
Detachment of Device or Device Component 1012 1012
Loss of or Failure to Bond 903 903
Adverse Event Without Identified Device or Use Problem 578 578
Contamination 575 575
Device Reprocessing Problem 490 490
Peeled/Delaminated 371 371
Device Contamination with Chemical or Other Material 335 335
Mechanical Problem 262 262
Contamination /Decontamination Problem 247 247
Fluid/Blood Leak 235 235
Crack 197 197
Use of Device Problem 176 176
Material Separation 146 146
Optical Obstruction 127 127
Material Split, Cut or Torn 104 104
Optical Problem 102 102
Obstruction of Flow 95 95
Mechanical Jam 91 91
Separation Problem 81 81
Device Fell 65 65
Insufficient Information 62 62
Material Discolored 55 55
Leak/Splash 53 53
Poor Quality Image 53 53
Corroded 50 50
Material Puncture/Hole 31 31
Erratic or Intermittent Display 29 29
No Display/Image 29 29
Optical Distortion 28 28
Material Frayed 27 27
Component Missing 26 26
Burst Container or Vessel 24 24
Physical Resistance/Sticking 24 24
Material Twisted/Bent 23 23
Appropriate Term/Code Not Available 22 22
Unintended Movement 22 22
Material Too Rigid or Stiff 22 22
Material Deformation 21 21
Difficult to Advance 21 21
Defective Component 20 20
Partial Blockage 18 18
Improper or Incorrect Procedure or Method 17 17
Device Dislodged or Dislocated 17 17
Dent in Material 17 17
Suction Problem 16 16
Device Contamination with Body Fluid 16 16
Degraded 16 16
Complete Blockage 15 15
Entrapment of Device 15 15
Structural Problem 14 14
Material Integrity Problem 14 14
Optical Discoloration 14 14
Positioning Problem 13 13
Difficult to Remove 13 13
Loose or Intermittent Connection 11 11
Difficult to Insert 11 11
Device Handling Problem 10 10
Device Damaged by Another Device 10 10
Misassembly by Users 9 9
Positioning Failure 9 9
Residue After Decontamination 9 9
Fracture 8 8
Collapse 7 7
Inflation Problem 7 7
Failure to Disconnect 7 7
Defective Device 7 7
Blocked Connection 7 7
Deformation Due to Compressive Stress 6 6
Failure to Advance 6 6
Activation, Positioning or Separation Problem 6 6
Scratched Material 6 6
Sharp Edges 6 6
Display or Visual Feedback Problem 6 6
Problem with Sterilization 5 5
Electrical Shorting 5 5
Material Protrusion/Extrusion 5 5
Device-Device Incompatibility 4 4
Communication or Transmission Problem 4 4
Premature Separation 4 4
No Apparent Adverse Event 4 4
Unexpected Therapeutic Results 4 4
Migration or Expulsion of Device 4 4
Image Display Error/Artifact 4 4
Restricted Flow rate 4 4
Flushing Problem 3 3
Labelling, Instructions for Use or Training Problem 3 3
Electrical /Electronic Property Problem 3 3
Difficult or Delayed Positioning 3 3
Device Difficult to Setup or Prepare 3 3
Tear, Rip or Hole in Device Packaging 3 3
Failure to Align 3 3
Output Problem 3 3
Device Contaminated at the User Facility 3 3
Failure to Eject 3 3
Contamination of Device Ingredient or Reagent 3 3
Difficult or Delayed Activation 3 3
Moisture or Humidity Problem 3 3

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 6762 6762
No Known Impact Or Consequence To Patient 1098 1098
No Consequences Or Impact To Patient 603 603
Foreign Body In Patient 237 237
No Patient Involvement 219 219
Hemorrhage/Bleeding 185 185
Unspecified Tissue Injury 184 184
Pancreatitis 158 158
Bacterial Infection 142 142
Unspecified Infection 123 123
Perforation 107 107
Laceration(s) 91 91
Unspecified Hepatic or Biliary Problem 78 78
Insufficient Information 70 70
Device Embedded In Tissue or Plaque 58 58
Injury 56 56
Inflammation 44 44
Abdominal Pain 30 30
Fever 28 28
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 27 27
Laceration(s) of Esophagus 22 22
Death 21 21
Bowel Burn 20 20
Perforation of Esophagus 18 18
Sepsis 18 18
Internal Organ Perforation 17 17
Pneumonia 16 16
Abscess 16 16
Vomiting 15 15
No Code Available 14 14
Blood Loss 13 13
Tissue Breakdown 12 12
Septic Shock 11 11
Pain 10 10
Airway Obstruction 10 10
Cough 10 10
Tissue Damage 9 9
Bowel Perforation 8 8
Fungal Infection 7 7
Obstruction/Occlusion 7 7
Abrasion 7 7
Fistula 6 6
Low Blood Pressure/ Hypotension 6 6
Gastrointestinal Hemorrhage 6 6
Drug Resistant Bacterial Infection 6 6
Patient Problem/Medical Problem 5 5
No Information 5 5
Nausea 5 5
Cardiac Arrest 5 5
Low Oxygen Saturation 5 5
Peritonitis 4 4
Adult Respiratory Distress Syndrome 4 4
Unspecified Gastrointestinal Problem 4 4
Swelling/ Edema 3 3
Thrombosis/Thrombus 3 3
Liver Damage/Dysfunction 3 3
High Blood Pressure/ Hypertension 3 3
Dysphagia/ Odynophagia 3 3
Hematoma 3 3
Fatigue 2 2
Diarrhea 2 2
Ulcer 2 2
Weakness 2 2
Pseudoaneurysm 2 2
Thromboembolism 2 2
Loss of consciousness 2 2
Scar Tissue 2 2
Sore Throat 2 2
Anxiety 2 2
Distress 2 2
Discomfort 2 2
Heart Failure/Congestive Heart Failure 2 2
Respiratory Arrest 2 2
Cancer 2 2
Needle Stick/Puncture 2 2
Unspecified Heart Problem 1 1
Bronchial Hemorrhage 1 1
Stenosis of the esophagus 1 1
Joint Dislocation 1 1
Intermenstrual Bleeding 1 1
Weight Changes 1 1
Cognitive Changes 1 1
Electric Shock 1 1
Diaphoresis 1 1
Urinary Frequency 1 1
Viral Infection 1 1
Vertigo 1 1
Pneumothorax 1 1
Renal Failure 1 1
Purulent Discharge 1 1
Dehydration 1 1
Chest Pain 1 1
Calcium Deposits/Calcification 1 1
Aspiration/Inhalation 1 1
Bruise/Contusion 1 1
Hemothorax 1 1
Extreme Exhaustion 1 1
Headache 1 1
Necrosis 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Boston Scientific Corporation II Nov-21-2023
2 Boston Scientific Corporation II May-13-2022
3 Boston Scientific Corporation III Apr-26-2021
4 Olympus Corporation of the Americas II Feb-09-2024
5 Olympus Corporation of the Americas II Aug-28-2023
6 Olympus Corporation of the Americas II May-19-2023
7 Olympus Corporation of the Americas II Dec-10-2021
8 Olympus Corporation of the Americas II Mar-22-2021
9 Pentax of America Inc II May-25-2021
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