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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 2325 2325

Device Problems MDRs with this Device Problem Events in those MDRs
Loss of or Failure to Bond 1692 1692
Microbial Contamination of Device 1166 1166
Break 659 659
Adverse Event Without Identified Device or Use Problem 508 508
Contamination 434 434
Device Contamination with Chemical or Other Material 315 315
Failure to Clean Adequately 310 310
Device Reprocessing Problem 310 310
Peeled/Delaminated 281 281
Detachment of Device or Device Component 237 237
Contamination /Decontamination Problem 223 223
Use of Device Problem 161 161
Fluid/Blood Leak 131 131
Material Separation 86 86
Mechanical Problem 83 83
Crack 81 81
Separation Problem 76 76
Insufficient Information 70 70
Device Fell 57 57
Appropriate Term/Code Not Available 55 55
Material Split, Cut or Torn 49 49
Optical Problem 38 38
Obstruction of Flow 30 30
Mechanical Jam 25 25
Material Puncture/Hole 24 24
Optical Distortion 21 21
Material Too Rigid or Stiff 19 19
No Display/Image 19 19
Material Frayed 19 19
Device Dislodged or Dislocated 17 17
Difficult to Advance 16 16
Material Twisted/Bent 16 16
Unintended Movement 16 16
Corroded 16 16
Improper or Incorrect Procedure or Method 16 16
Component Missing 16 16
Dent in Material 15 15
Entrapment of Device 14 14
Partial Blockage 13 13
Defective Component 13 13
Physical Resistance/Sticking 13 13
Structural Problem 12 12
Material Deformation 11 11
Material Integrity Problem 11 11
Positioning Problem 11 11
Leak/Splash 10 10
Collapse 9 9
Poor Quality Image 9 9
Device Handling Problem 9 9
Misassembly by Users 8 8
Degraded 8 8
Material Discolored 7 7
Loose or Intermittent Connection 7 7
Difficult to Insert 7 7
Fracture 7 7
Device Damaged by Another Device 7 7
Failure to Disconnect 7 7
Defective Device 7 7
Activation, Positioning or Separation Problem 6 6
Deformation Due to Compressive Stress 6 6
Positioning Failure 6 6
Complete Blockage 6 6
Burst Container or Vessel 6 6
Residue After Decontamination 6 6
Suction Problem 5 5
Migration or Expulsion of Device 5 5
Difficult to Remove 5 5
Inflation Problem 5 5
Electrical Shorting 5 5
Material Protrusion/Extrusion 4 4
No Apparent Adverse Event 4 4
Sharp Edges 4 4
Unexpected Therapeutic Results 4 4
Display or Visual Feedback Problem 4 4
Image Display Error/Artifact 3 3
Labelling, Instructions for Use or Training Problem 3 3
Device Contaminated at the User Facility 3 3
Optical Obstruction 3 3
Output Problem 3 3
Device-Device Incompatibility 3 3
Device Contamination With Biological Material 3 3
Failure to Advance 3 3
Blocked Connection 3 3
Difficult or Delayed Activation 3 3
Patient-Device Incompatibility 2 2
Failure to Align 2 2
Contamination of Device Ingredient or Reagent 2 2
Component or Accessory Incompatibility 2 2
Device Operates Differently Than Expected 2 2
Infusion or Flow Problem 2 2
Scratched Material 2 2
Naturally Worn 2 2
Failure to Eject 2 2
Premature Separation 2 2
Material Fragmentation 2 2
Electrical /Electronic Property Problem 2 2
Erratic or Intermittent Display 2 2
Restricted Flow rate 2 2
Accessory Incompatible 2 2
Difficult or Delayed Positioning 2 2

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 2843 2843
No Known Impact Or Consequence To Patient 2063 2063
No Consequences Or Impact To Patient 636 636
No Patient Involvement 304 304
Unspecified Infection 156 156
Foreign Body In Patient 155 155
Hemorrhage/Bleeding 137 137
Bacterial Infection 136 136
Unspecified Tissue Injury 121 121
Perforation 88 88
Laceration(s) 83 83
Injury 82 82
Pancreatitis 79 79
Inflammation 78 78
No Code Available 50 50
Unspecified Hepatic or Biliary Problem 50 50
Insufficient Information 49 49
Death 37 37
Abdominal Pain 21 21
Bowel Burn 20 20
Pneumonia 15 15
Fever 14 14
Blood Loss 14 14
Tissue Breakdown 12 12
Laceration(s) of Esophagus 12 12
Perforation of Esophagus 11 11
Pain 11 11
No Information 11 11
Device Embedded In Tissue or Plaque 11 11
Vomiting 10 10
Tissue Damage 9 9
Abscess 9 9
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 9 9
Sepsis 8 8
Septic Shock 8 8
Fungal Infection 7 7
Bowel Perforation 7 7
Abrasion 7 7
Internal Organ Perforation 7 7
Low Blood Pressure/ Hypotension 6 6
Cough 6 6
Drug Resistant Bacterial Infection 5 5
Fistula 5 5
Patient Problem/Medical Problem 5 5
Obstruction/Occlusion 5 5
Low Oxygen Saturation 4 4
Nausea 4 4
Gastrointestinal Hemorrhage 4 4
Swelling/ Edema 3 3
Hematoma 3 3
Liver Damage/Dysfunction 3 3
Dysphagia/ Odynophagia 3 3
Scar Tissue 3 3
Cancer 3 3
Thrombosis/Thrombus 3 3
Heart Failure/Congestive Heart Failure 2 2
Pseudoaneurysm 2 2
Loss of consciousness 2 2
Ulcer 2 2
Distress 2 2
Shock 2 2
Weakness 2 2
Fatigue 2 2
Diarrhea 2 2
Cardiac Arrest 2 2
Not Applicable 2 2
Stenosis of the esophagus 1 1
Chest Pain 1 1
Headache 1 1
Air Embolism 1 1
Airway Obstruction 1 1
Burn(s) 1 1
Calcium Deposits/Calcification 1 1
Hemothorax 1 1
Necrosis 1 1
Pneumothorax 1 1
Renal Failure 1 1
Respiratory Distress 1 1
Staphylococcus Aureus 1 1
Chills 1 1
Viral Infection 1 1
Peritonitis 1 1
Urinary Retention 1 1
Vertigo 1 1
Complaint, Ill-Defined 1 1
Joint Dislocation 1 1
Sore Throat 1 1
Diaphoresis 1 1
Shaking/Tremors 1 1
Cognitive Changes 1 1
Electric Shock 1 1
Unspecified Heart Problem 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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