Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

New Search show TPLC since Back to Search Results
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 2
FUJIFILM CORPORATION
  SUBSTANTIALLY EQUIVALENT 4
FUJIFILM MEDICAL SYSTEMS U.S.A., INC.
  SUBSTANTIALLY EQUIVALENT 1
OLYMPUS MEDICAL SYSTEMS CORP.
  SUBSTANTIALLY EQUIVALENT 4
PENTAX MEDICAL
  SUBSTANTIALLY EQUIVALENT 3
PENTAX MEDICAL COMPANY
  SUBSTANTIALLY EQUIVALENT 1
PENTAX OF AMERICA, INC.
  SUBSTANTIALLY EQUIVALENT 5

MDR Year MDR Reports MDR Events
2014 35 35
2015 246 246
2016 247 247
2017 791 791
2018 481 481
2019 1347 1347
2020 822 822
2021 1270 1270
2022 2619 2619
2023 3050 3050
2024 2183 2183

Device Problems MDRs with this Device Problem Events in those MDRs
Failure to Clean Adequately 2307 2307
Microbial Contamination of Device 1735 1735
Loss of or Failure to Bond 1695 1695
Break 1181 1181
Detachment of Device or Device Component 1157 1157
Adverse Event Without Identified Device or Use Problem 804 804
Contamination 642 642
Device Reprocessing Problem 626 626
Peeled/Delaminated 386 386
Device Contamination with Chemical or Other Material 341 341
Mechanical Problem 279 279
Contamination /Decontamination Problem 263 263
Fluid/Blood Leak 251 251
Crack 224 224
Material Separation 191 191
Use of Device Problem 178 178
Optical Obstruction 173 173
Insufficient Information 149 149
Optical Problem 125 125
Material Split, Cut or Torn 118 118
Obstruction of Flow 116 116
Material Discolored 106 106
Mechanical Jam 98 98
Corroded 89 89
Separation Problem 83 83
Device Fell 68 68
Poor Quality Image 66 66
Leak/Splash 65 65
Appropriate Term/Code Not Available 56 56
Erratic or Intermittent Display 46 46
No Display/Image 41 41
Material Puncture/Hole 38 38
Burst Container or Vessel 32 32
Optical Discoloration 31 31
Material Frayed 29 29
Optical Distortion 29 29
Material Too Rigid or Stiff 28 28
Physical Resistance/Sticking 27 27
Component Missing 26 26
Defective Component 25 25
Unintended Movement 23 23
Difficult to Advance 23 23
Material Twisted/Bent 23 23
Device Dislodged or Dislocated 22 22
Material Deformation 21 21
Degraded 20 20
Partial Blockage 19 19
Entrapment of Device 18 18
Complete Blockage 18 18
Improper or Incorrect Procedure or Method 18 18

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 7885 7885
No Known Impact Or Consequence To Patient 2084 2084
No Consequences Or Impact To Patient 707 707
Bacterial Infection 510 510
No Patient Involvement 356 356
Foreign Body In Patient 249 249
Unspecified Infection 247 254
Hemorrhage/Bleeding 201 201
Unspecified Tissue Injury 184 184
Pancreatitis 173 173
Perforation 119 119
Laceration(s) 100 100
Death 99 99
Inflammation 85 85
Injury 84 84
Unspecified Hepatic or Biliary Problem 82 82
Insufficient Information 74 74
Device Embedded In Tissue or Plaque 59 59
No Code Available 55 55
Fever 38 38
Abdominal Pain 34 34
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 27 27
Sepsis 27 27
Laceration(s) of Esophagus 23 23
Perforation of Esophagus 21 21
Pneumonia 20 20
Bowel Burn 20 20
Vomiting 19 19
Internal Organ Perforation 19 19
Abscess 18 18
Pain 16 16
Blood Loss 15 15
No Information 13 13
Septic Shock 12 12
Tissue Breakdown 12 12
Bowel Perforation 12 12
Tissue Damage 10 10
Cough 10 10
Airway Obstruction 10 10
Fungal Infection 8 8
Nausea 8 8
Obstruction/Occlusion 8 8
Low Blood Pressure/ Hypotension 7 7
Not Applicable 7 7
Abrasion 7 7
Gastrointestinal Hemorrhage 6 6
Peritonitis 6 6
Fistula 6 6
Drug Resistant Bacterial Infection 6 6
Cancer 6 6

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 Fujifilm Medical Systems U.S.A., Inc. II Sep-27-2017
5 Fujifilm Medical Systems U.S.A., Inc. II Sep-13-2017
6 Fujifilm Medical Systems U.S.A., Inc. II May-31-2016
7 Fujifilm Medical Systems U.S.A., Inc. II Dec-15-2015
8 Fujifilm Medical Systems U.S.A., Inc. II Sep-17-2015
9 Olympus America Inc. II Sep-22-2015
10 Olympus Corporation of the Americas II Feb-09-2024
11 Olympus Corporation of the Americas II Aug-28-2023
12 Olympus Corporation of the Americas II May-19-2023
13 Olympus Corporation of the Americas II Dec-10-2021
14 Olympus Corporation of the Americas II Mar-22-2021
15 Olympus Corporation of the Americas II May-31-2016
16 Olympus Corporation of the Americas II Feb-04-2016
17 Pentax Medical Company II Jul-23-2016
18 Pentax Medical Company II May-27-2016
19 Pentax of America Inc II May-25-2021
20 Pentax of America Inc II Feb-20-2018
21 Pentax of America Inc II Jul-11-2017
-
-