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

MDR Year MDR Reports MDR Events
2020 822 822
2021 1270 1270
2022 2619 2619
2023 3050 3050
2024 3021 3021
2025 273 273

Device Problems MDRs with this Device Problem Events in those MDRs
Failure to Clean Adequately 2664 2664
Detachment of Device or Device Component 1306 1306
Break 1186 1186
Microbial Contamination of Device 1027 1027
Contamination 610 610
Device Reprocessing Problem 585 585
Adverse Event Without Identified Device or Use Problem 530 530
Peeled/Delaminated 395 395
Device Contamination with Chemical or Other Material 336 336
Mechanical Problem 281 281
Fluid/Blood Leak 257 257
Contamination /Decontamination Problem 248 248
Crack 239 239
Optical Obstruction 222 222
Material Separation 213 213
Optical Problem 183 183
Use of Device Problem 178 178
Obstruction of Flow 146 146
Material Split, Cut or Torn 132 132
Material Discolored 121 121
Loss of or Failure to Bond 110 110
Mechanical Jam 109 109
Separation Problem 87 87
Poor Quality Image 84 84
Corroded 82 82
Device Fell 73 73
Leak/Splash 68 68
Insufficient Information 63 63
Erratic or Intermittent Display 61 61
No Display/Image 52 52
Optical Discoloration 37 37
Material Puncture/Hole 37 37
Burst Container or Vessel 35 35
Physical Resistance/Sticking 31 31
Material Frayed 30 30
Material Too Rigid or Stiff 28 28
Optical Distortion 28 28
Partial Blockage 27 27
Component Missing 27 27
Defective Component 27 27
Difficult to Advance 26 26
Material Twisted/Bent 25 25
Unintended Movement 24 24
Degraded 24 24
Material Deformation 22 22
Device Dislodged or Dislocated 20 20
Appropriate Term/Code Not Available 20 20
Difficult to Remove 20 20
Complete Blockage 19 19
Positioning Problem 18 18

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 8890 8890
No Consequences Or Impact To Patient 505 505
Foreign Body In Patient 266 266
Hemorrhage/Bleeding 219 219
Pancreatitis 202 202
Unspecified Tissue Injury 184 184
Bacterial Infection 150 150
No Known Impact Or Consequence To Patient 139 139
Perforation 127 127
Laceration(s) 100 100
Unspecified Infection 99 99
No Patient Involvement 99 99
Unspecified Hepatic or Biliary Problem 82 82
Insufficient Information 76 76
Device Embedded In Tissue or Plaque 55 55
Sepsis 43 43
Abdominal Pain 35 35
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 34 34
Laceration(s) of Esophagus 26 26
Fever 24 24
Perforation of Esophagus 24 24
Bowel Burn 20 20
Abscess 19 19
Internal Organ Perforation 19 19
Vomiting 18 18
Pneumonia 16 16
Inflammation 16 16
Drug Resistant Bacterial Infection 15 15
Airway Obstruction 14 14
Bowel Perforation 13 13
Pain 12 12
Tissue Breakdown 12 12
Septic Shock 11 11
Injury 10 10
Cough 10 10
Blood Loss 10 10
Tissue Damage 9 9
No Code Available 9 9
Death 9 9
Obstruction/Occlusion 8 8
Nausea 8 8
Abrasion 7 7
Fistula 7 7
Fungal Infection 7 7
Low Blood Pressure/ Hypotension 6 6
Cardiac Arrest 6 6
Gastrointestinal Hemorrhage 6 6
Low Oxygen Saturation 5 5
Hematoma 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
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