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

MDR Year MDR Reports MDR Events
2019 1347 1347
2020 822 824
2021 1270 1270
2022 2619 2619
2023 3050 3050
2024 3019 3019
2025 2779 2779

Device Problems MDRs with this Device Problem Events in those MDRs
Failure to Clean Adequately 3218 3218
Microbial Contamination of Device 1557 1557
Detachment of Device or Device Component 1488 1488
Break 1256 1256
Loss of or Failure to Bond 910 910
Device Reprocessing Problem 898 898
Adverse Event Without Identified Device or Use Problem 703 703
Peeled/Delaminated 661 661
Contamination 642 642
Crack 532 532
Device Contamination with Chemical or Other Material 340 340
Mechanical Problem 300 300
Fluid/Blood Leak 266 266
Contamination /Decontamination Problem 263 263
Material Separation 244 244
Optical Obstruction 236 236
Optical Problem 224 224
Use of Device Problem 180 180
Material Split, Cut or Torn 180 180
Obstruction of Flow 174 174
Material Discolored 169 169
Residue After Decontamination 146 146
Corroded 142 142
Mechanical Jam 126 126
Poor Quality Image 100 100
Degraded 91 91
Flare or Flash 91 91
Separation Problem 89 89
Device Fell 85 85
Insufficient Information 76 76
Leak/Splash 72 72
No Display/Image 70 72
Erratic or Intermittent Display 69 69
Thermal Decomposition of Device 68 68
Melted 67 67
Material Deformation 65 65
Material Puncture/Hole 56 56
Material Fragmentation 52 52
Scratched Material 46 46
Optical Discoloration 42 42
Physical Resistance/Sticking 41 41
Burst Container or Vessel 36 36
Material Frayed 33 33
Positioning Failure 32 32
Difficult to Remove 31 31
Difficult to Advance 30 30
Component Missing 30 30
Partial Blockage 29 29
Optical Distortion 28 28
Material Too Rigid or Stiff 28 28

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 11282 11282
No Known Impact Or Consequence To Patient 1098 1100
No Consequences Or Impact To Patient 603 603
Foreign Body In Patient 290 290
Pancreatitis 237 237
Hemorrhage/Bleeding 233 233
No Patient Involvement 219 219
Bacterial Infection 189 189
Unspecified Tissue Injury 184 184
Perforation 152 152
Unspecified Infection 136 136
Insufficient Information 104 104
Laceration(s) 104 104
Unspecified Hepatic or Biliary Problem 90 90
Device Embedded In Tissue or Plaque 60 60
Injury 56 56
Sepsis 47 47
Inflammation 44 44
Abdominal Pain 38 38
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 38 38
Fever 28 28
Perforation of Esophagus 26 26
Abscess 26 26
Laceration(s) of Esophagus 26 26
Internal Organ Perforation 24 24
Death 21 21
Bowel Perforation 21 21
Bowel Burn 20 20
Vomiting 19 19
Airway Obstruction 18 18
Pneumonia 18 18
Gastrointestinal Hemorrhage 16 16
Septic Shock 15 15
Drug Resistant Bacterial Infection 15 15
Cough 15 15
No Code Available 14 14
Pain 13 13
Blood Loss 13 13
Tissue Breakdown 12 12
Obstruction/Occlusion 10 10
Tissue Damage 9 9
Peritonitis 8 8
Nausea 8 8
Abrasion 7 7
Cardiac Arrest 7 7
Fungal Infection 7 7
Fistula 7 7
Low Blood Pressure/ Hypotension 6 6
Pulmonary Edema 5 5
Hematoma 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
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