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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device bronchoscope accessory
Definition 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 CodeKTI
Regulation Number 874.4680
Device Class 2


Premarket Reviews
ManufacturerDecision
ACCLARENT, INC.
  SUBSTANTIALLY EQUIVALENT 2
BOSTON SCIENTIFIC CORPORATION
  SUBSTANTIALLY EQUIVALENT 1
BRYAN MEDICAL , INC.
  SUBSTANTIALLY EQUIVALENT 1
DISA MEDINOTEC
  SUBSTANTIALLY EQUIVALENT 1
DONGGUAN TT MEDICAL, INC.
  SUBSTANTIALLY EQUIVALENT 1
GA HEALTH COMPANY LIMITED
  SUBSTANTIALLY EQUIVALENT 1
INTUIT MEDICAL PRODUCTS, LLC
  SUBSTANTIALLY EQUIVALENT 1
M/S MERIL LIFE SCIENCES PVT. LTD.
  SUBSTANTIALLY EQUIVALENT 1
MEDIVATORS, INC.
  SUBSTANTIALLY EQUIVALENT 1
MERIT MEDICAL SYSTEMS, INC.
  SUBSTANTIALLY EQUIVALENT 2
MICRO-TECH (NANJING) CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
OLYMPUS MEDICAL SYSTEMS CORP.
  SUBSTANTIALLY EQUIVALENT 1
OLYMPUS SURGICAL TECHNOLOGIES AMERICA
  SUBSTANTIALLY EQUIVALENT 4
PRAXIS MEDICAL, LLC
  SUBSTANTIALLY EQUIVALENT 1
SERPEX MEDICAL, INC.
  SUBSTANTIALLY EQUIVALENT 1
SPIRATION, INC.
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2014 4 4
2015 2 2
2016 7 7
2017 9 9
2018 14 14
2019 27 27
2020 37 37
2021 47 47
2022 131 131
2023 130 130
2024 57 57

Device Problems MDRs with this Device Problem Events in those MDRs
Break 83 83
Mechanical Problem 58 58
Detachment of Device or Device Component 50 50
Retraction Problem 35 35
Burst Container or Vessel 34 34
Material Puncture/Hole 28 28
Leak/Splash 26 26
Material Separation 25 25
Adverse Event Without Identified Device or Use Problem 22 22
Material Twisted/Bent 22 22
Physical Resistance/Sticking 20 20
Use of Device Problem 17 17
Device Fell 12 12
Defective Device 10 10
Difficult to Remove 8 8
Difficult to Advance 7 7
Material Split, Cut or Torn 7 7
Unintended Movement 7 7
Mechanical Jam 6 6
Output Problem 5 5
Material Deformation 5 5
Separation Failure 5 5
Device Slipped 5 5
Material Fragmentation 5 5
Deflation Problem 5 5
Inflation Problem 4 4
Component Missing 4 4
Failure to Obtain Sample 4 4
Deformation Due to Compressive Stress 4 4
Separation Problem 4 4
Insufficient Information 3 3
Failure to Advance 3 3
Device Dislodged or Dislocated 3 3
Defective Component 3 3
Entrapment of Device 3 3
Unstable 2 2
Material Perforation 2 2
Improper or Incorrect Procedure or Method 2 2
Suction Problem 1 1
Fitting Problem 1 1
Material Too Rigid or Stiff 1 1
Bent 1 1
Microbial Contamination of Device 1 1
Cut In Material 1 1
Fluid/Blood Leak 1 1
Fracture 1 1
Hole In Material 1 1
Difficult to Insert 1 1
Loose or Intermittent Connection 1 1
Difficult or Delayed Positioning 1 1
Disassembly 1 1
Failure to Discharge 1 1
Disconnection 1 1
Display or Visual Feedback Problem 1 1
Device Reprocessing Problem 1 1
Collapse 1 1
Detachment Of Device Component 1 1
Failure To Unwrap 1 1
Inadequate User Interface 1 1
Compatibility Problem 1 1
Material Integrity Problem 1 1
Difficult to Open or Close 1 1
Failure to Disconnect 1 1
Activation, Positioning or Separation Problem 1 1
Device Markings/Labelling Problem 1 1
Device Handling Problem 1 1
Activation Failure 1 1
Positioning Problem 1 1
Scratched Material 1 1
Torn Material 1 1
Fail-Safe Did Not Operate 1 1
Ejection Problem 1 1
Failure to Eject 1 1
Firing Problem 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 316 316
No Consequences Or Impact To Patient 55 55
Foreign Body In Patient 27 27
No Known Impact Or Consequence To Patient 27 27
Insufficient Information 11 11
Hemorrhage/Bleeding 6 6
No Code Available 5 5
Hypoxia 3 3
Unspecified Infection 2 2
Device Embedded In Tissue or Plaque 2 2
Pneumothorax 2 2
Abscess 2 2
Chest Pain 2 2
Embolism 1 1
Fever 1 1
Hemoptysis 1 1
Airway Obstruction 1 1
Bacterial Infection 1 1
Cardiac Arrest 1 1
Foreign body, removal of 1 1
Breathing difficulties 1 1
Tooth Fracture 1 1
Needle Stick/Puncture 1 1
Low Oxygen Saturation 1 1
Respiratory Failure 1 1
Decreased Respiratory Rate 1 1
Sleep Dysfunction 1 1
No Patient Involvement 1 1
Scar Tissue 1 1
Perforation of Vessels 1 1
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 1 1
Cough 1 1
Unspecified Respiratory Problem 1 1
Unspecified Tissue Injury 1 1
No Information 1 1
Pneumonia 1 1
Low Blood Pressure/ Hypotension 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Acclarent, Inc. II Aug-01-2013
2 Acclarent, Inc. I Mar-01-2012
3 Bryan Medical Inc II Jul-17-2023
4 Richard Wolf GmbH II Feb-06-2019
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