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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
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 2
OLYMPUS MEDICAL SYSTEMS CORP.
  SUBSTANTIALLY EQUIVALENT 6
PENTAX OF AMERICA, INC.
  SUBSTANTIALLY EQUIVALENT 3

MDR Year MDR Reports MDR Events
2020 822 824
2021 1270 1270
2022 2619 2619
2023 3050 3050
2024 3019 3019
2025 3984 3985
2026 4157 4157

Device Problems MDRs with this Device Problem Events in those MDRs
Failure to Clean Adequately 3952 3952
Peeled/Delaminated 2024 2024
Detachment of Device or Device Component 1870 1870
Crack 1634 1634
Break 1447 1447
Microbial Contamination of Device 1347 1347
Device Reprocessing Problem 1215 1215
Contamination 667 667
Adverse Event Without Identified Device or Use Problem 605 605
Degraded 535 535
Corroded 448 448
Residue After Decontamination 361 361
Device Contamination with Chemical or Other Material 340 340
Material Separation 337 337
Material Split, Cut or Torn 314 314
Mechanical Problem 298 298
Fluid/Blood Leak 273 273
Contamination /Decontamination Problem 273 273
Material Discolored 273 273
Material Fragmentation 265 265
Optical Problem 251 251
Optical Obstruction 244 244
Obstruction of Flow 204 205
Flare or Flash 188 188
Use of Device Problem 180 180
Thermal Decomposition of Device 179 179
Mechanical Jam 155 155
Material Deformation 153 153
Melted 141 141
Material Puncture/Hole 138 138
Loss of or Failure to Bond 135 135
Poor Quality Image 118 118
Scratched Material 115 115
Device Fell 97 97
Separation Problem 96 96
No Display/Image 85 87
Overheating of Device 82 82
Leak/Splash 75 75
Erratic or Intermittent Display 72 72
Insufficient Information 70 70
Material Integrity Problem 67 67
Physical Resistance/Sticking 62 62
Optical Discoloration 46 46
Difficult to Advance 45 45
Naturally Worn 41 41
Burst Container or Vessel 40 40
Positioning Failure 39 39
Component Missing 38 38
Device Dislodged or Dislocated 37 37
Excessive Heating 35 35

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 16572 16573
No Consequences Or Impact To Patient 505 505
Foreign Body In Patient 304 304
Pancreatitis 251 251
Hemorrhage/Bleeding 243 243
Unspecified Tissue Injury 185 185
Bacterial Infection 166 166
Perforation 149 149
No Known Impact Or Consequence To Patient 139 141
Insufficient Information 119 119
Unspecified Infection 107 107
Laceration(s) 103 103
No Patient Involvement 99 99
Unspecified Hepatic or Biliary Problem 90 90
Device Embedded In Tissue or Plaque 57 57
Sepsis 48 48
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 45 45
Abdominal Pain 42 42
Fever 27 27
Perforation of Esophagus 27 27
Laceration(s) of Esophagus 26 26
Airway Obstruction 26 26
Abscess 25 25
Internal Organ Perforation 24 24
Bowel Perforation 23 23
Bowel Burn 20 20
Vomiting 19 19
Cough 19 19
Gastrointestinal Hemorrhage 19 19
Pain 17 17
Septic Shock 17 17
Pneumonia 16 16
Inflammation 16 16
Drug Resistant Bacterial Infection 15 15
Tissue Breakdown 12 12
Obstruction/Occlusion 10 10
Blood Loss 10 10
Injury 10 10
Death 9 9
No Code Available 9 9
Tissue Damage 9 9
Peritonitis 9 9
Low Oxygen Saturation 9 9
Low Blood Pressure/ Hypotension 8 8
Nausea 8 8
Discomfort 7 7
Abrasion 7 7
Fistula 7 7
Fungal Infection 7 7
Cardiac Arrest 7 7

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 Nov-21-2025
5 Olympus Corporation of the Americas II Feb-09-2024
6 Olympus Corporation of the Americas II Aug-28-2023
7 Olympus Corporation of the Americas II May-19-2023
8 Olympus Corporation of the Americas II Dec-10-2021
9 Olympus Corporation of the Americas II Mar-22-2021
10 Pentax of America Inc II May-25-2021
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