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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 A/S
  SUBSTANTIALLY EQUIVALENT 1
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 5

MDR Year MDR Reports MDR Events
2018 481 481
2019 1347 1347
2020 822 822
2021 1270 1270
2022 2619 2619
2023 3050 3050
2024 2430 2430

Device Problems MDRs with this Device Problem Events in those MDRs
Failure to Clean Adequately 2413 2413
Microbial Contamination of Device 1440 1440
Detachment of Device or Device Component 1179 1179
Break 1179 1179
Loss of or Failure to Bond 1085 1085
Adverse Event Without Identified Device or Use Problem 679 679
Contamination 585 585
Device Reprocessing Problem 577 577
Peeled/Delaminated 389 389
Device Contamination with Chemical or Other Material 335 335
Mechanical Problem 281 281
Fluid/Blood Leak 253 253
Contamination /Decontamination Problem 249 249
Crack 228 228
Material Separation 206 206
Optical Obstruction 183 183
Use of Device Problem 180 180
Optical Problem 147 147
Material Split, Cut or Torn 123 123
Obstruction of Flow 116 116
Material Discolored 111 111
Mechanical Jam 99 99
Separation Problem 85 85
Insufficient Information 84 84
Corroded 73 73
Device Fell 68 68
Leak/Splash 65 65
Poor Quality Image 65 65
Erratic or Intermittent Display 48 48
No Display/Image 40 40
Material Puncture/Hole 40 40
Optical Discoloration 34 34
Burst Container or Vessel 33 33
Material Frayed 29 29
Optical Distortion 29 29
Appropriate Term/Code Not Available 29 29
Physical Resistance/Sticking 28 28
Material Too Rigid or Stiff 27 27
Defective Component 26 26
Component Missing 26 26
Unintended Movement 24 24
Material Twisted/Bent 24 24
Difficult to Advance 22 22
Device Dislodged or Dislocated 21 21
Material Deformation 21 21
Degraded 21 21
Partial Blockage 19 19
Complete Blockage 17 17
Entrapment of Device 17 17
Improper or Incorrect Procedure or Method 17 17

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 8119 8119
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 251 251
Hemorrhage/Bleeding 203 203
Unspecified Tissue Injury 184 184
Pancreatitis 176 176
Bacterial Infection 173 173
Unspecified Infection 155 155
Perforation 114 114
Laceration(s) 100 100
Unspecified Hepatic or Biliary Problem 82 82
Inflammation 81 81
Injury 75 75
Insufficient Information 74 74
Device Embedded In Tissue or Plaque 58 58
No Code Available 37 37
Abdominal Pain 34 34
Fever 31 31
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 27 27
Death 26 26
Laceration(s) of Esophagus 23 23
Perforation of Esophagus 22 22
Bowel Burn 20 20
Internal Organ Perforation 19 19
Vomiting 18 18
Sepsis 18 18
Abscess 18 18
Pneumonia 16 16
Blood Loss 14 14
Pain 13 13
Tissue Breakdown 12 12
Bowel Perforation 11 11
Septic Shock 11 11
Cough 10 10
Airway Obstruction 10 10
Tissue Damage 9 9
No Information 8 8
Obstruction/Occlusion 8 8
Nausea 8 8
Abrasion 7 7
Fungal Infection 7 7
Gastrointestinal Hemorrhage 6 6
Low Blood Pressure/ Hypotension 6 6
Drug Resistant Bacterial Infection 6 6
Fistula 6 6
Hematoma 5 5
Cardiac Arrest 5 5
Peritonitis 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
10 Pentax of America Inc II Feb-20-2018
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