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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 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 430 430

Device Problems MDRs with this Device Problem Events in those MDRs
Failure to Clean Adequately 1483 1483
Microbial Contamination of Device 1176 1176
Break 1094 1094
Detachment of Device or Device Component 925 925
Loss of or Failure to Bond 902 902
Contamination 573 573
Adverse Event Without Identified Device or Use Problem 551 551
Device Reprocessing Problem 462 462
Peeled/Delaminated 364 364
Device Contamination with Chemical or Other Material 335 335
Mechanical Problem 259 259
Contamination /Decontamination Problem 247 247
Fluid/Blood Leak 228 228
Use of Device Problem 176 176
Crack 154 154
Material Separation 134 134
Optical Obstruction 108 108
Material Split, Cut or Torn 97 97
Mechanical Jam 90 90
Optical Problem 87 87
Obstruction of Flow 87 87
Separation Problem 81 81
Device Fell 65 65
Insufficient Information 62 62
Poor Quality Image 50 50
Material Discolored 46 46
Corroded 43 43
Leak/Splash 43 43
Material Puncture/Hole 30 30
Optical Distortion 28 28
Material Frayed 27 27
Component Missing 25 25
No Display/Image 24 24
Physical Resistance/Sticking 24 24
Erratic or Intermittent Display 23 23
Burst Container or Vessel 22 22
Material Too Rigid or Stiff 22 22
Unintended Movement 22 22
Appropriate Term/Code Not Available 22 22
Material Deformation 21 21
Material Twisted/Bent 21 21
Difficult to Advance 21 21
Defective Component 20 20
Improper or Incorrect Procedure or Method 17 17
Partial Blockage 17 17
Device Dislodged or Dislocated 17 17
Dent in Material 17 17
Suction Problem 16 16
Device Contamination with Body Fluid 16 16
Entrapment of Device 15 15
Complete Blockage 14 14
Structural Problem 14 14
Difficult to Remove 13 13
Degraded 13 13
Material Integrity Problem 13 13
Positioning Problem 13 13
Difficult to Insert 11 11
Loose or Intermittent Connection 10 10
Device Handling Problem 10 10
Device Damaged by Another Device 10 10
Optical Discoloration 9 9
Misassembly by Users 9 9
Positioning Failure 9 9
Fracture 8 8
Residue After Decontamination 8 8
Collapse 7 7
Blocked Connection 7 7
Failure to Disconnect 7 7
Defective Device 7 7
Deformation Due to Compressive Stress 6 6
Activation, Positioning or Separation Problem 6 6
Sharp Edges 6 6
Display or Visual Feedback Problem 6 6
Inflation Problem 6 6
Failure to Advance 6 6
Problem with Sterilization 5 5
Scratched Material 5 5
Electrical Shorting 5 5
Material Protrusion/Extrusion 5 5
Communication or Transmission Problem 4 4
No Apparent Adverse Event 4 4
Premature Separation 4 4
Migration or Expulsion of Device 4 4
Unexpected Therapeutic Results 4 4
Restricted Flow rate 4 4
Image Display Error/Artifact 4 4
Labelling, Instructions for Use or Training Problem 3 3
Electrical /Electronic Property Problem 3 3
Flushing Problem 3 3
Difficult or Delayed Positioning 3 3
Device Difficult to Setup or Prepare 3 3
Failure to Align 3 3
Tear, Rip or Hole in Device Packaging 3 3
Device Contaminated at the User Facility 3 3
Output Problem 3 3
Failure to Eject 3 3
Difficult or Delayed Activation 3 3
Contamination of Device Ingredient or Reagent 3 3
Device Sensing Problem 3 3
Device-Device Incompatibility 3 3

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 6245 6245
No Known Impact Or Consequence To Patient 1098 1098
No Consequences Or Impact To Patient 603 603
Foreign Body In Patient 225 225
No Patient Involvement 219 219
Unspecified Tissue Injury 184 184
Hemorrhage/Bleeding 182 182
Pancreatitis 143 143
Bacterial Infection 142 142
Unspecified Infection 123 123
Perforation 105 105
Laceration(s) 91 91
Unspecified Hepatic or Biliary Problem 77 77
Insufficient Information 66 66
Injury 56 56
Inflammation 44 44
Device Embedded In Tissue or Plaque 34 34
Abdominal Pain 29 29
Fever 27 27
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 27 27
Death 21 21
Laceration(s) of Esophagus 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
Tissue Damage 9 9
Airway Obstruction 9 9
Cough 9 9
Bowel Perforation 8 8
Abrasion 7 7
Fungal Infection 7 7
Obstruction/Occlusion 7 7
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
Fistula 5 5
Cardiac Arrest 5 5
Low Oxygen Saturation 5 5
Peritonitis 4 4
Adult Respiratory Distress Syndrome 4 4
Dysphagia/ Odynophagia 3 3
Hematoma 3 3
Liver Damage/Dysfunction 3 3
High Blood Pressure/ Hypertension 3 3
Thrombosis/Thrombus 3 3
Swelling/ Edema 3 3
Unspecified Gastrointestinal Problem 3 3
Heart Failure/Congestive Heart Failure 2 2
Respiratory Arrest 2 2
Cancer 2 2
Needle Stick/Puncture 2 2
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
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
Unspecified Heart Problem 1 1
Bronchial Hemorrhage 1 1
Stenosis of the esophagus 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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