• 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
Regulation Description Endoscope and accessories.
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
FUJIFILM CORPORATION
  SUBSTANTIALLY EQUIVALENT 1
OLYMPUS MEDICAL SYSTEMS CORP.
  SUBSTANTIALLY EQUIVALENT 3
PENTAX OF AMERICA, INC.
  SUBSTANTIALLY EQUIVALENT 3

MDR Year MDR Reports MDR Events
2020 822 822
2021 1270 1270
2022 2619 2619
2023 3050 3050
2024 3020 3020
2025 853 853

Device Problems MDRs with this Device Problem Events in those MDRs
Failure to Clean Adequately 2844 2844
Detachment of Device or Device Component 1380 1380
Break 1199 1199
Microbial Contamination of Device 1057 1057
Device Reprocessing Problem 686 686
Contamination 621 621
Adverse Event Without Identified Device or Use Problem 562 562
Peeled/Delaminated 398 398
Device Contamination with Chemical or Other Material 338 338
Mechanical Problem 290 290
Fluid/Blood Leak 261 261
Contamination /Decontamination Problem 256 256
Crack 248 248
Optical Obstruction 226 226
Material Separation 216 216
Optical Problem 196 196
Use of Device Problem 179 179
Obstruction of Flow 158 158
Material Split, Cut or Torn 137 137
Material Discolored 125 125
Mechanical Jam 117 117
Loss of or Failure to Bond 110 110
Poor Quality Image 91 91
Corroded 90 90
Separation Problem 87 87
Device Fell 81 81
Leak/Splash 69 69
Insufficient Information 64 64
Erratic or Intermittent Display 62 62
No Display/Image 55 55
Residue After Decontamination 39 39
Optical Discoloration 38 38
Material Puncture/Hole 38 38
Physical Resistance/Sticking 37 37
Burst Container or Vessel 35 35
Material Frayed 32 32
Material Too Rigid or Stiff 28 28
Degraded 28 28
Optical Distortion 28 28
Component Missing 28 28
Material Deformation 28 28
Partial Blockage 27 27
Defective Component 27 27
Difficult to Advance 27 27
Unintended Movement 25 25
Material Twisted/Bent 25 25
Device Dislodged or Dislocated 24 24
Difficult to Remove 22 22
Complete Blockage 22 22
Improper or Incorrect Procedure or Method 20 20

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 9411 9411
No Consequences Or Impact To Patient 505 505
Foreign Body In Patient 278 278
Hemorrhage/Bleeding 228 228
Pancreatitis 226 226
Unspecified Tissue Injury 184 184
Bacterial Infection 154 154
Perforation 145 145
No Known Impact Or Consequence To Patient 139 139
Unspecified Infection 101 101
Laceration(s) 101 101
No Patient Involvement 99 99
Insufficient Information 88 88
Unspecified Hepatic or Biliary Problem 85 85
Device Embedded In Tissue or Plaque 57 57
Sepsis 47 47
Abdominal Pain 37 37
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 34 34
Laceration(s) of Esophagus 26 26
Internal Organ Perforation 24 24
Perforation of Esophagus 24 24
Fever 24 24
Bowel Burn 20 20
Abscess 19 19
Airway Obstruction 18 18
Vomiting 18 18
Pneumonia 16 16
Inflammation 16 16
Drug Resistant Bacterial Infection 15 15
Cough 15 15
Bowel Perforation 14 14
Gastrointestinal Hemorrhage 13 13
Tissue Breakdown 12 12
Pain 12 12
Septic Shock 11 11
Injury 10 10
Blood Loss 10 10
Tissue Damage 9 9
Death 9 9
No Code Available 9 9
Obstruction/Occlusion 8 8
Nausea 8 8
Abrasion 7 7
Fistula 7 7
Cardiac Arrest 7 7
Fungal Infection 7 7
Low Blood Pressure/ Hypotension 6 6
Aspiration Pneumonitis 5 5
Peritonitis 5 5
Low Oxygen Saturation 5 5

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
-
-