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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 4
FUJIFILM MEDICAL SYSTEMS U.S.A., INC.
  SUBSTANTIALLY EQUIVALENT 1
OLYMPUS MEDICAL SYSTEMS CORP.
  SUBSTANTIALLY EQUIVALENT 3
PENTAX MEDICAL
  SUBSTANTIALLY EQUIVALENT 3
PENTAX OF AMERICA, INC.
  SUBSTANTIALLY EQUIVALENT 4

MDR Year MDR Reports MDR Events
2017 791 791
2018 481 481
2019 1347 1347
2020 822 822
2021 1270 1270
2022 757 757

Device Problems MDRs with this Device Problem Events in those MDRs
Loss of or Failure to Bond 1692 1692
Microbial Contamination of Device 1078 1078
Break 450 450
Adverse Event Without Identified Device or Use Problem 430 430
Device Contamination with Chemical or Other Material 305 305
Device Reprocessing Problem 238 238
Contamination /Decontamination Problem 182 182
Use of Device Problem 129 129
Contamination 123 123
Detachment of Device or Device Component 121 121
Failure to Clean Adequately 119 119
Fluid Leak 71 71
Insufficient Information 68 68
Peeled/Delaminated 64 64
Mechanical Problem 60 60
Material Separation 55 55
Appropriate Term/Code Not Available 54 54
Device Fell 48 48
Crack 45 45
Optical Problem 27 27
Material Split, Cut or Torn 24 24
No Display/Image 19 19
Material Puncture/Hole 19 19
Improper or Incorrect Procedure or Method 15 15
Device Dislodged or Dislocated 15 15
Material Too Rigid or Stiff 14 14
Dent in Material 14 14
Defective Component 13 13
Unintended Movement 13 13
Structural Problem 12 12
Corroded 12 12
Material Frayed 11 11
Leak/Splash 10 10
Entrapment of Device 10 10
Material Twisted/Bent 10 10
Difficult to Advance 10 10
Material Integrity Problem 9 9
Physical Resistance/Sticking 9 9
Partial Blockage 9 9
Positioning Problem 8 8
Misassembly by Users 7 7
Material Deformation 7 7
Mechanical Jam 7 7
Defective Device 7 7
Collapse 7 7
Obstruction of Flow 7 7
Residue After Decontamination 6 6
Failure to Disconnect 6 6
Poor Quality Image 6 6
Loose or Intermittent Connection 6 6
Deformation Due to Compressive Stress 6 6
Activation, Positioning or SeparationProblem 6 6
Optical Distortion 6 6
Electrical Shorting 5 5
Device Handling Problem 5 5
Separation Problem 5 5
Inflation Problem 5 5
Fracture 5 5
Material Discolored 5 5
Degraded 4 4
Complete Blockage 4 4
Component Missing 4 4
Sharp Edges 4 4
No Apparent Adverse Event 4 4
Device Damaged by Another Device 4 4
Material Protrusion/Extrusion 4 4
Output Problem 3 3
Device-Device Incompatibility 3 3
Device Contamination With Biological Material 3 3
Failure to Advance 3 3
Device Contaminated at the User Facility 3 3
Labelling, Instructions for Use or Training Problem 3 3
Difficult to Remove 3 3
Positioning Failure 3 3
Display or Visual Feedback Problem 3 3
Image Display Error/Artifact 3 3
Migration or Expulsion of Device 3 3
Difficult to Insert 2 2
Erratic or Intermittent Display 2 2
Restricted Flow rate 2 2
Burst Container or Vessel 2 2
Accessory Incompatible 2 2
Problem with Sterilization 2 2
Device Difficult to Setup or Prepare 2 2
Difficult or Delayed Activation 2 2
Failure to Align 2 2
Premature Separation 2 2
Blocked Connection 2 2
Patient-Device Incompatibility 2 2
Component or Accessory Incompatibility 2 2
Device Operates Differently Than Expected 2 2
Naturally Worn 2 2
Operating System Becomes Nonfunctional 1 1
Optical Discoloration 1 1
Optical Obstruction 1 1
Improper Chemical Reaction 1 1
Compatibility Problem 1 1
Infusion or Flow Problem 1 1
Device Markings/Labelling Problem 1 1
Failure of Device to Self-Test 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Known Impact Or Consequence To Patient 2063 2063
No Clinical Signs, Symptoms or Conditions 1541 1541
No Consequences Or Impact To Patient 636 636
No Patient Involvement 304 304
Unspecified Infection 144 144
Bacterial Infection 115 115
Unspecified Tissue Injury 97 97
Hemorrhage/Bleeding 94 94
Injury 82 82
Inflammation 78 78
Laceration(s) 69 69
Perforation 61 61
No Code Available 50 50
Pancreatitis 48 48
Foreign Body In Patient 37 37
Death 37 37
Insufficient Information 35 35
Unspecified Hepatic or Biliary Problem 26 26
Bowel Burn 20 20
Abdominal Pain 14 14
Fever 14 14
Blood Loss 14 14
Tissue Breakdown 12 12
No Information 11 11
Pneumonia 11 11
Pain 11 11
Laceration(s) of Esophagus 10 10
Perforation of Esophagus 9 9
Device Embedded In Tissue or Plaque 9 9
Tissue Damage 9 9
Abscess 8 8
Abrasion 7 7
Sepsis 6 6
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 6 6
Low Blood Pressure/ Hypotension 5 5
Internal Organ Perforation 5 5
Fistula 5 5
Patient Problem/Medical Problem 5 5
Drug Resistant Bacterial Infection 5 5
Vomiting 5 5
Bowel Perforation 5 5
Fungal Infection 4 4
Obstruction/Occlusion 3 3
Low Oxygen Saturation 3 3
Gastrointestinal Hemorrhage 3 3
Thrombosis/Thrombus 3 3
Scar Tissue 3 3
Septic Shock 3 3
Liver Damage/Dysfunction 3 3
Swelling/ Edema 3 3
Nausea 2 2
Shock 2 2
Diarrhea 2 2
Fatigue 2 2
Hematoma 2 2
Cardiac Arrest 2 2
Heart Failure/Congestive Heart Failure 2 2
Not Applicable 2 2
Cancer 2 2
Weakness 2 2
Ulcer 2 2
Complaint, Ill-Defined 1 1
Chills 1 1
Diaphoresis 1 1
Shaking/Tremors 1 1
Cognitive Changes 1 1
Electric Shock 1 1
Joint Dislocation 1 1
Sore Throat 1 1
Cough 1 1
Stenosis of the esophagus 1 1
Chest Pain 1 1
Burn(s) 1 1
Air Embolism 1 1
Hemothorax 1 1
Dysphagia/ Odynophagia 1 1
Headache 1 1
Urinary Retention 1 1
Vertigo 1 1
Necrosis 1 1
Pneumothorax 1 1
Respiratory Distress 1 1
Staphylococcus Aureus 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Boston Scientific Corporation II May-13-2022
2 Boston Scientific Corporation III Apr-26-2021
3 Fujifilm Medical Systems U.S.A., Inc. II Sep-27-2017
4 Fujifilm Medical Systems U.S.A., Inc. II Sep-13-2017
5 Olympus Corporation of the Americas II Dec-10-2021
6 Olympus Corporation of the Americas II Mar-22-2021
7 Pentax of America Inc II May-25-2021
8 Pentax of America Inc II Feb-20-2018
9 Pentax of America Inc II Jul-11-2017
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