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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
FUJIFILM CORPORATION
  SUBSTANTIALLY EQUIVALENT 1
OLYMPUS MEDICAL SYSTEMS CORP.
  SUBSTANTIALLY EQUIVALENT 4
PENTAX OF AMERICA, INC.
  SUBSTANTIALLY EQUIVALENT 3

MDR Year MDR Reports MDR Events
2021 1270 1270
2022 2619 2619
2023 3050 3050
2024 3019 3019
2025 3984 3985
2026 2192 2192

Device Problems MDRs with this Device Problem Events in those MDRs
Failure to Clean Adequately 3724 3724
Peeled/Delaminated 1740 1740
Detachment of Device or Device Component 1615 1615
Break 1193 1193
Crack 1118 1118
Microbial Contamination of Device 1071 1071
Device Reprocessing Problem 990 990
Contamination 661 661
Adverse Event Without Identified Device or Use Problem 532 532
Corroded 320 320
Degraded 318 318
Material Separation 282 282
Mechanical Problem 272 272
Device Contamination with Chemical or Other Material 271 271
Material Split, Cut or Torn 270 270
Fluid/Blood Leak 257 257
Contamination /Decontamination Problem 256 256
Residue After Decontamination 246 246
Optical Obstruction 244 244
Optical Problem 243 243
Material Discolored 231 231
Obstruction of Flow 196 197
Use of Device Problem 179 179
Thermal Decomposition of Device 148 148
Mechanical Jam 142 142
Flare or Flash 142 142
Material Fragmentation 132 132
Melted 130 130
Material Deformation 123 123
Poor Quality Image 108 108
Material Puncture/Hole 96 96
Separation Problem 92 92
Scratched Material 85 85
No Display/Image 81 81
Device Fell 81 81
Leak/Splash 73 73
Erratic or Intermittent Display 70 70
Overheating of Device 68 68
Physical Resistance/Sticking 55 55
Material Integrity Problem 55 55
Insufficient Information 53 53
Loss of or Failure to Bond 51 51
Optical Discoloration 46 46
Positioning Failure 39 39
Burst Container or Vessel 39 39
Difficult to Advance 37 37
Component Missing 37 37
Difficult to Remove 33 33
Material Frayed 32 32
Excessive Heating 30 30

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 14599 14600
Foreign Body In Patient 292 292
Pancreatitis 242 242
Hemorrhage/Bleeding 220 220
Unspecified Tissue Injury 184 184
Bacterial Infection 138 138
Perforation 138 138
Insufficient Information 113 113
Laceration(s) 99 99
Unspecified Hepatic or Biliary Problem 90 90
Unspecified Infection 68 68
No Consequences Or Impact To Patient 61 61
Device Embedded In Tissue or Plaque 56 56
Sepsis 46 46
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 40 40
Abdominal Pain 39 39
Perforation of Esophagus 26 26
Fever 25 25
Internal Organ Perforation 23 23
Laceration(s) of Esophagus 23 23
Airway Obstruction 22 22
Bowel Perforation 21 21
Abscess 20 20
Bowel Burn 20 20
Cough 19 19
Gastrointestinal Hemorrhage 19 19
Pain 17 17
Vomiting 17 17
Septic Shock 17 17
No Patient Involvement 16 16
Drug Resistant Bacterial Infection 15 15
Tissue Breakdown 12 12
Inflammation 10 10
Low Oxygen Saturation 9 9
Peritonitis 9 9
Pneumonia 8 8
Obstruction/Occlusion 8 8
Low Blood Pressure/ Hypotension 8 8
Abrasion 7 7
Discomfort 7 7
Cardiac Arrest 7 7
Nausea 6 6
Increased Respiratory Rate 6 6
Fistula 6 6
Pulmonary Edema 5 5
Hematoma 5 5
Aspiration Pneumonitis 5 5
Unspecified Gastrointestinal Problem 4 4
Wheezing 4 4
Respiratory Failure 4 4

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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