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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 5200 5200

Device Problems MDRs with this Device Problem Events in those MDRs
Failure to Clean Adequately 4037 4037
Peeled/Delaminated 2082 2082
Detachment of Device or Device Component 1934 1934
Crack 1902 1902
Device Reprocessing Problem 1318 1318
Break 1295 1295
Microbial Contamination of Device 1115 1115
Contamination 670 670
Degraded 654 654
Corroded 517 517
Adverse Event Without Identified Device or Use Problem 510 510
Residue After Decontamination 440 440
Material Separation 361 361
Material Fragmentation 334 334
Material Split, Cut or Torn 324 324
Material Discolored 292 292
Mechanical Problem 275 275
Device Contamination with Chemical or Other Material 270 270
Contamination /Decontamination Problem 260 260
Fluid/Blood Leak 258 258
Optical Problem 250 250
Optical Obstruction 246 246
Flare or Flash 221 221
Obstruction of Flow 204 205
Material Puncture/Hole 195 195
Thermal Decomposition of Device 186 186
Use of Device Problem 179 179
Material Deformation 174 174
Mechanical Jam 154 154
Melted 143 143
Scratched Material 132 132
Poor Quality Image 116 116
Separation Problem 95 95
Overheating of Device 86 86
No Display/Image 86 86
Device Fell 82 82
Loss of or Failure to Bond 78 78
Erratic or Intermittent Display 74 74
Leak/Splash 72 72
Material Integrity Problem 70 70
Physical Resistance/Sticking 58 58
Insufficient Device Problem Information 52 52
Optical Discoloration 47 47
Naturally Worn 45 45
Burst Container or Vessel 41 41
Positioning Failure 40 40
Difficult to Advance 38 38
Excessive Heating 37 37
Difficult to Remove 34 34
Component Missing 34 34

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 17552 17553
Foreign Body In Patient 300 300
Pancreatitis 263 263
Hemorrhage/Blood Loss/Bleeding 229 229
Unspecified Tissue Injury 184 184
Perforation 144 144
Bacterial Infection 144 144
Insufficient Information 119 119
Laceration(s) 99 99
Cholangitis 96 96
Unspecified Hepatic or Biliary Problem 90 90
Unspecified Infection 73 73
No Consequences Or Impact To Patient 61 61
Device Embedded In Tissue or Plaque 56 56
Abdominal Pain 53 53
Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available 47 47
Sepsis 46 46
Fever 26 26
Airway Obstruction 26 26
Perforation of Esophagus 26 26
Laceration(s) of Esophagus 23 23
Internal Organ Perforation 23 23
Bowel Perforation 22 22
Abscess 20 20
Bowel Burn 20 20
Vomiting 19 19
Gastrointestinal Hemorrhage 19 19
Cough 19 19
Pain 17 17
Septic Shock 17 17
No Patient Involvement 16 16
Drug Resistant Bacterial Infection 15 15
Bacteremia 12 12
Tissue Breakdown 12 12
Pneumonia 11 11
Inflammation 10 10
Low Oxygen Saturation 9 9
Peritonitis 9 9
Nausea 8 8
Obstruction/Occlusion 8 8
Low Blood Pressure/ Hypotension 8 8
Abrasion 7 7
Cardiac Arrest 7 7
Discomfort 7 7
Increased Respiratory Rate 6 6
Fistula 6 6
Hematoma 5 5
Aspiration Pneumonitis 5 5
Pulmonary Edema 5 5
Adult Respiratory Distress Syndrome 4 4

Recalls
Manufacturer Recall Class Date Posted
1 Boston Scientific Corporation II Jul-01-2026
2 Boston Scientific Corporation II Nov-21-2023
3 Boston Scientific Corporation II May-13-2022
4 Boston Scientific Corporation III Apr-26-2021
5 Olympus Corporation of the Americas II Jul-07-2026
6 Olympus Corporation of the Americas II Nov-21-2025
7 Olympus Corporation of the Americas II Feb-09-2024
8 Olympus Corporation of the Americas II Aug-28-2023
9 Olympus Corporation of the Americas II May-19-2023
10 Olympus Corporation of the Americas II Dec-10-2021
11 Olympus Corporation of the Americas II Mar-22-2021
12 Pentax of America Inc II May-25-2021
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