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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
OLYMPUS MEDICAL SYSTEMS CORP.
  SUBSTANTIALLY EQUIVALENT 3
PENTAX MEDICAL
  SUBSTANTIALLY EQUIVALENT 2
PENTAX OF AMERICA, INC.
  SUBSTANTIALLY EQUIVALENT 4

MDR Year MDR Reports MDR Events
2018 481 481
2019 1347 1347
2020 822 822
2021 1270 1270
2022 2619 2619
2023 1844 1844

Device Problems MDRs with this Device Problem Events in those MDRs
Microbial Contamination of Device 1227 1227
Loss of or Failure to Bond 1082 1082
Break 944 944
Failure to Clean Adequately 854 854
Detachment of Device or Device Component 757 757
Adverse Event Without Identified Device or Use Problem 579 579
Contamination 553 553
Device Reprocessing Problem 420 420
Peeled/Delaminated 345 345
Device Contamination with Chemical or Other Material 332 332
Contamination /Decontamination Problem 246 246
Fluid/Blood Leak 192 192
Use of Device Problem 171 171
Mechanical Problem 119 119
Crack 115 115
Material Separation 107 107
Material Split, Cut or Torn 83 83
Separation Problem 82 82
Mechanical Jam 82 82
Insufficient Information 74 74
Device Fell 65 65
Obstruction of Flow 63 63
Optical Obstruction 58 58
Optical Problem 54 54
Optical Distortion 29 29
Appropriate Term/Code Not Available 29 29
Component Missing 25 25
Material Puncture/Hole 25 25
Corroded 23 23
Material Frayed 23 23
Unintended Movement 22 22
Material Too Rigid or Stiff 21 21
Material Twisted/Bent 20 20
Physical Resistance/Sticking 19 19
No Display/Image 19 19
Improper or Incorrect Procedure or Method 17 17
Material Deformation 17 17
Device Dislodged or Dislocated 17 17
Difficult to Advance 17 17
Dent in Material 17 17
Defective Component 16 16
Partial Blockage 16 16
Leak/Splash 16 16
Suction Problem 15 15
Device Contamination with Body Fluid 14 14
Poor Quality Image 14 14
Entrapment of Device 14 14
Degraded 13 13
Complete Blockage 13 13
Material Integrity Problem 13 13
Positioning Problem 12 12
Structural Problem 12 12
Difficult to Remove 11 11
Burst Container or Vessel 10 10
Loose or Intermittent Connection 10 10
Device Damaged by Another Device 10 10
Misassembly by Users 9 9
Device Handling Problem 9 9
Difficult to Insert 9 9
Erratic or Intermittent Display 9 9
Collapse 9 9
Material Discolored 9 9
Positioning Failure 8 8
Fracture 8 8
Residue After Decontamination 7 7
Failure to Disconnect 7 7
Defective Device 7 7
Blocked Connection 6 6
Deformation Due to Compressive Stress 6 6
Failure to Advance 6 6
Activation, Positioning or Separation Problem 6 6
Electrical Shorting 5 5
Material Protrusion/Extrusion 5 5
Inflation Problem 5 5
Migration or Expulsion of Device 5 5
Display or Visual Feedback Problem 5 5
Restricted Flow rate 4 4
Unexpected Therapeutic Results 4 4
Patient-Device Incompatibility 4 4
No Apparent Adverse Event 4 4
Scratched Material 4 4
Sharp Edges 4 4
Premature Separation 4 4
Failure to Eject 3 3
Device Contaminated at the User Facility 3 3
Output Problem 3 3
Difficult or Delayed Activation 3 3
Contamination of Device Ingredient or Reagent 3 3
Communication or Transmission Problem 3 3
Device-Device Incompatibility 3 3
Failure to Align 3 3
Device Difficult to Setup or Prepare 3 3
Labelling, Instructions for Use or Training Problem 3 3
Image Display Error/Artifact 3 3
Electrical /Electronic Property Problem 3 3
Difficult or Delayed Positioning 3 3
Accessory Incompatible 2 2
Material Fragmentation 2 2
Flushing Problem 2 2
Retraction Problem 2 2

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 4721 4721
No Known Impact Or Consequence To Patient 1400 1400
No Consequences Or Impact To Patient 618 618
No Patient Involvement 264 264
Foreign Body In Patient 209 209
Unspecified Tissue Injury 182 182
Hemorrhage/Bleeding 182 182
Unspecified Infection 142 142
Bacterial Infection 139 139
Pancreatitis 118 118
Perforation 106 106
Laceration(s) 89 89
Inflammation 75 75
Injury 75 75
Unspecified Hepatic or Biliary Problem 68 68
Insufficient Information 65 65
No Code Available 37 37
Death 26 26
Device Embedded In Tissue or Plaque 25 25
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 25 25
Abdominal Pain 23 23
Bowel Burn 20 20
Fever 16 16
Laceration(s) of Esophagus 16 16
Perforation of Esophagus 16 16
Pneumonia 16 16
Vomiting 14 14
Abscess 14 14
Blood Loss 14 14
Pain 13 13
Tissue Breakdown 12 12
Septic Shock 11 11
Internal Organ Perforation 11 11
Sepsis 10 10
Tissue Damage 9 9
No Information 8 8
Bowel Perforation 8 8
Cough 8 8
Fungal Infection 7 7
Obstruction/Occlusion 7 7
Abrasion 7 7
Low Blood Pressure/ Hypotension 6 6
Gastrointestinal Hemorrhage 6 6
Drug Resistant Bacterial Infection 6 6
Patient Problem/Medical Problem 5 5
Nausea 5 5
Fistula 5 5
Low Oxygen Saturation 5 5
Adult Respiratory Distress Syndrome 4 4
Cardiac Arrest 3 3
Dysphagia/ Odynophagia 3 3
Hematoma 3 3
Liver Damage/Dysfunction 3 3
Scar Tissue 3 3
Cancer 3 3
Thrombosis/Thrombus 3 3
Swelling/ Edema 3 3
Unspecified Gastrointestinal Problem 3 3
Heart Failure/Congestive Heart Failure 2 2
Not Applicable 2 2
Needle Stick/Puncture 2 2
Pseudoaneurysm 2 2
Shock 2 2
Weakness 2 2
Peritonitis 2 2
Ulcer 2 2
Loss of consciousness 2 2
Sore Throat 2 2
Anxiety 2 2
Distress 2 2
Discomfort 2 2
Fatigue 2 2
Diarrhea 2 2
Purulent Discharge 1 1
Dehydration 1 1
Chest Pain 1 1
Calcium Deposits/Calcification 1 1
Air Embolism 1 1
Airway Obstruction 1 1
Aspiration/Inhalation 1 1
Bruise/Contusion 1 1
Hemothorax 1 1
High Blood Pressure/ Hypertension 1 1
Extreme Exhaustion 1 1
Headache 1 1
Necrosis 1 1
Complaint, Ill-Defined 1 1
Joint Dislocation 1 1
Diaphoresis 1 1
Shaking/Tremors 1 1
Cognitive Changes 1 1
Electric Shock 1 1
Urinary Frequency 1 1
Viral Infection 1 1
Chills 1 1
Vertigo 1 1
Pneumothorax 1 1
Renal Failure 1 1
Staphylococcus Aureus 1 1
Weight Changes 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 Olympus Corporation of the Americas II Aug-28-2023
4 Olympus Corporation of the Americas II May-19-2023
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
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