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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 2183 2183

Device Problems MDRs with this Device Problem Events in those MDRs
Failure to Clean Adequately 2306 2306
Microbial Contamination of Device 1275 1275
Break 1164 1164
Detachment of Device or Device Component 1157 1157
Loss of or Failure to Bond 904 904
Adverse Event Without Identified Device or Use Problem 600 600
Contamination 582 582
Device Reprocessing Problem 540 540
Peeled/Delaminated 386 386
Device Contamination with Chemical or Other Material 335 335
Mechanical Problem 277 277
Fluid/Blood Leak 251 251
Contamination /Decontamination Problem 247 247
Crack 222 222
Material Separation 191 191
Use of Device Problem 177 177
Optical Obstruction 173 173
Optical Problem 125 125
Material Split, Cut or Torn 118 118
Obstruction of Flow 114 114
Material Discolored 106 106
Mechanical Jam 98 98
Separation Problem 82 82
Corroded 70 70
Device Fell 68 68
Insufficient Information 66 66
Poor Quality Image 64 64
Leak/Splash 63 63
Erratic or Intermittent Display 46 46
Material Puncture/Hole 37 37
No Display/Image 36 36
Burst Container or Vessel 32 32
Optical Discoloration 30 30
Optical Distortion 28 28
Material Frayed 28 28
Physical Resistance/Sticking 27 27
Component Missing 26 26
Material Too Rigid or Stiff 26 26
Defective Component 24 24
Material Twisted/Bent 23 23
Unintended Movement 23 23
Difficult to Advance 22 22
Appropriate Term/Code Not Available 22 22
Material Deformation 21 21
Device Dislodged or Dislocated 21 21
Degraded 20 20
Partial Blockage 19 19
Dent in Material 17 17
Entrapment of Device 17 17
Improper or Incorrect Procedure or Method 17 17

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 7885 7885
No Known Impact Or Consequence To Patient 1098 1098
No Consequences Or Impact To Patient 603 603
Foreign Body In Patient 246 246
No Patient Involvement 219 219
Hemorrhage/Bleeding 195 195
Unspecified Tissue Injury 184 184
Pancreatitis 173 173
Bacterial Infection 157 157
Unspecified Infection 126 126
Perforation 111 111
Laceration(s) 100 100
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 33 33
Fever 28 28
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 27 27
Laceration(s) of Esophagus 22 22
Death 21 21
Perforation of Esophagus 20 20
Bowel Burn 20 20
Internal Organ Perforation 19 19
Sepsis 18 18
Abscess 18 18
Vomiting 18 18
Pneumonia 16 16
No Code Available 14 14
Blood Loss 13 13
Tissue Breakdown 12 12
Bowel Perforation 11 11
Septic Shock 11 11
Pain 10 10
Cough 10 10
Airway Obstruction 10 10
Tissue Damage 9 9
Nausea 8 8
Obstruction/Occlusion 8 8
Fungal Infection 7 7
Abrasion 7 7
Low Blood Pressure/ Hypotension 6 6
Gastrointestinal Hemorrhage 6 6
Fistula 6 6
Drug Resistant Bacterial Infection 6 6
Cardiac Arrest 5 5
Peritonitis 5 5
Hematoma 5 5
Low Oxygen Saturation 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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