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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 1731 1731

Device Problems MDRs with this Device Problem Events in those MDRs
Failure to Clean Adequately 2089 2089
Microbial Contamination of Device 1251 1251
Break 1151 1151
Detachment of Device or Device Component 1107 1107
Loss of or Failure to Bond 903 903
Adverse Event Without Identified Device or Use Problem 591 591
Contamination 580 580
Device Reprocessing Problem 529 529
Peeled/Delaminated 383 383
Device Contamination with Chemical or Other Material 335 335
Mechanical Problem 267 267
Fluid/Blood Leak 248 248
Contamination /Decontamination Problem 247 247
Crack 216 216
Use of Device Problem 176 176
Material Separation 168 168
Optical Obstruction 153 153
Optical Problem 116 116
Material Split, Cut or Torn 111 111
Obstruction of Flow 107 107
Mechanical Jam 95 95
Material Discolored 84 84
Separation Problem 81 81
Device Fell 65 65
Corroded 63 63
Insufficient Information 62 62
Poor Quality Image 60 60
Leak/Splash 58 58
Erratic or Intermittent Display 36 36
Material Puncture/Hole 35 35
No Display/Image 32 32
Burst Container or Vessel 29 29
Material Frayed 28 28
Optical Distortion 28 28
Optical Discoloration 27 27
Physical Resistance/Sticking 26 26
Material Too Rigid or Stiff 26 26
Component Missing 26 26
Unintended Movement 23 23
Material Twisted/Bent 23 23
Appropriate Term/Code Not Available 22 22
Defective Component 22 22
Material Deformation 21 21
Difficult to Advance 21 21
Partial Blockage 18 18
Degraded 18 18
Entrapment of Device 17 17
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
Complete Blockage 16 16
Difficult to Remove 15 15
Material Integrity Problem 15 15
Positioning Problem 15 15
Structural Problem 14 14
Difficult to Insert 13 13
Device Damaged by Another Device 12 12
Loose or Intermittent Connection 11 11
Positioning Failure 11 11
Device Handling Problem 10 10
Misassembly by Users 9 9
Residue After Decontamination 9 9
Inflation Problem 8 8
Fracture 8 8
Moisture or Humidity Problem 8 8
Failure to Disconnect 7 7
Defective Device 7 7
Blocked Connection 7 7
Collapse 7 7
Display or Visual Feedback Problem 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
Electrical Shorting 5 5
Material Protrusion/Extrusion 5 5
Problem with Sterilization 5 5
Tear, Rip or Hole in Device Packaging 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
Device-Device Incompatibility 4 4
Communication or Transmission Problem 4 4
Premature Separation 4 4
No Apparent Adverse Event 4 4
Naturally Worn 3 3
Output Problem 3 3
Failure to Eject 3 3
Device Contaminated at the User Facility 3 3
Patient Device Interaction Problem 3 3
Connection Problem 3 3
Contamination of Device Ingredient or Reagent 3 3
Difficult or Delayed Activation 3 3
Failure to Align 3 3
Device Sensing Problem 3 3
Infusion or Flow Problem 3 3

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 7455 7455
No Known Impact Or Consequence To Patient 1098 1098
No Consequences Or Impact To Patient 603 603
Foreign Body In Patient 239 239
No Patient Involvement 219 219
Hemorrhage/Bleeding 191 191
Unspecified Tissue Injury 184 184
Pancreatitis 168 168
Bacterial Infection 152 152
Unspecified Infection 126 126
Perforation 109 109
Laceration(s) 98 98
Unspecified Hepatic or Biliary Problem 81 81
Insufficient Information 73 73
Device Embedded In Tissue or Plaque 58 58
Injury 56 56
Inflammation 44 44
Abdominal Pain 33 33
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 19 19
Internal Organ Perforation 19 19
Vomiting 18 18
Sepsis 18 18
Abscess 18 18
Pneumonia 16 16
No Code Available 14 14
Blood Loss 13 13
Tissue Breakdown 12 12
Bowel Perforation 11 11
Septic Shock 11 11
Pain 10 10
Airway Obstruction 10 10
Cough 10 10
Tissue Damage 9 9
Nausea 8 8
Abrasion 7 7
Fungal Infection 7 7
Obstruction/Occlusion 7 7
Low Blood Pressure/ Hypotension 6 6
Fistula 6 6
Gastrointestinal Hemorrhage 6 6
Drug Resistant Bacterial Infection 6 6
Patient Problem/Medical Problem 5 5
No Information 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
Dysphagia/ Odynophagia 3 3
Hematoma 3 3
High Blood Pressure/ Hypertension 3 3
Liver Damage/Dysfunction 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
Aspiration Pneumonitis 2 2
Respiratory Arrest 2 2
Cancer 2 2
Needle Stick/Puncture 2 2
Bronchial Hemorrhage 1 1
Unspecified Heart Problem 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
Cyst(s) 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

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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