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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
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 3
PENTAX MEDICAL
  SUBSTANTIALLY EQUIVALENT 1
PENTAX OF AMERICA, INC.
  SUBSTANTIALLY EQUIVALENT 4

MDR Year MDR Reports MDR Events
2019 1347 1347
2020 822 822
2021 1270 1270
2022 2619 2619
2023 3050 3050
2024 2939 2939

Device Problems MDRs with this Device Problem Events in those MDRs
Failure to Clean Adequately 2598 2598
Microbial Contamination of Device 1340 1340
Detachment of Device or Device Component 1248 1248
Break 1188 1188
Loss of or Failure to Bond 905 905
Adverse Event Without Identified Device or Use Problem 631 631
Contamination 603 603
Device Reprocessing Problem 589 589
Peeled/Delaminated 392 392
Device Contamination with Chemical or Other Material 335 335
Mechanical Problem 285 285
Fluid/Blood Leak 255 255
Contamination /Decontamination Problem 248 248
Crack 233 233
Material Separation 218 218
Optical Obstruction 200 200
Use of Device Problem 179 179
Optical Problem 170 170
Material Split, Cut or Torn 127 127
Obstruction of Flow 126 126
Material Discolored 120 120
Mechanical Jam 104 104
Separation Problem 87 87
Corroded 82 82
Poor Quality Image 82 82
Device Fell 70 70
Insufficient Information 70 70
Leak/Splash 68 68
Erratic or Intermittent Display 54 54
No Display/Image 45 45
Material Puncture/Hole 41 41
Optical Discoloration 37 37
Burst Container or Vessel 33 33
Material Frayed 31 31
Physical Resistance/Sticking 30 30
Material Too Rigid or Stiff 28 28
Optical Distortion 28 28
Defective Component 27 27
Component Missing 27 27
Material Twisted/Bent 25 25
Difficult to Advance 24 24
Unintended Movement 24 24
Degraded 24 24
Appropriate Term/Code Not Available 22 22
Partial Blockage 22 22
Device Dislodged or Dislocated 21 21
Material Deformation 21 21
Complete Blockage 18 18
Positioning Problem 18 18
Dent in Material 17 17

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 8570 8570
No Known Impact Or Consequence To Patient 1098 1098
No Consequences Or Impact To Patient 603 603
Foreign Body In Patient 255 255
No Patient Involvement 219 219
Hemorrhage/Bleeding 213 213
Pancreatitis 194 194
Unspecified Tissue Injury 184 184
Bacterial Infection 180 180
Unspecified Infection 129 129
Perforation 123 123
Laceration(s) 101 101
Unspecified Hepatic or Biliary Problem 82 82
Insufficient Information 74 74
Device Embedded In Tissue or Plaque 58 58
Injury 56 56
Inflammation 44 44
Abdominal Pain 35 35
Sepsis 34 34
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 29 29
Fever 28 28
Laceration(s) of Esophagus 23 23
Perforation of Esophagus 23 23
Death 21 21
Bowel Burn 20 20
Internal Organ Perforation 19 19
Abscess 18 18
Vomiting 18 18
Pneumonia 16 16
No Code Available 14 14
Airway Obstruction 14 14
Drug Resistant Bacterial Infection 13 13
Blood Loss 13 13
Pain 12 12
Tissue Breakdown 12 12
Bowel Perforation 11 11
Septic Shock 11 11
Cough 10 10
Tissue Damage 9 9
Nausea 8 8
Obstruction/Occlusion 8 8
Abrasion 7 7
Fungal Infection 7 7
Fistula 7 7
Low Blood Pressure/ Hypotension 6 6
Cardiac Arrest 6 6
Gastrointestinal Hemorrhage 6 6
Low Oxygen Saturation 5 5
Peritonitis 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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