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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device dislodger, stone, biliary
Product CodeLQR
Regulation Number 876.5010
Device Class 2


Premarket Reviews
ManufacturerDecision
BOSTON SCIENTIFIC CORPORATION
  SUBSTANTIALLY EQUIVALENT 1
  SUBSTANTIALLY EQUIVALENT - KIT 1
COOK INCORPORATED
  SUBSTANTIALLY EQUIVALENT - KIT 1
  SUBSTANTIALLY EQUIVALENT 3
HANGZHOU AGS MEDTECH CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
OLYMPUS MEDICAL SYSTEMS CORP.
  SUBSTANTIALLY EQUIVALENT 1
WILSON-COOK MEDICAL, INC
  SUBSTANTIALLY EQUIVALENT 1
WILSON-COOK MEDICAL, INC.
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2017 11 11
2018 43 43
2019 41 41
2020 51 51
2021 47 47
2022 15 15

Device Problems MDRs with this Device Problem Events in those MDRs
Break 117 117
Positioning Problem 25 25
Material Separation 18 18
Difficult to Remove 17 17
Adverse Event Without Identified Device or Use Problem 7 7
Material Rupture 6 6
Detachment of Device or Device Component 6 6
Difficult to Fold, Unfold or Collapse 5 5
Fracture 4 4
Material Deformation 4 4
Failure to Advance 3 3
Failure to Conduct 3 3
Entrapment of Device 2 2
Difficult to Advance 2 2
Difficult to Open or Close 2 2
Failure to Align 2 2
Mechanical Jam 2 2
Separation Problem 2 2
Failure to Deflate 1 1
Material Split, Cut or Torn 1 1
Defective Device 1 1
Material Integrity Problem 1 1
Material Twisted/Bent 1 1
Device Contamination with Chemical or Other Material 1 1
Use of Device Problem 1 1
Fitting Problem 1 1
Component Missing 1 1
Tear, Rip or Hole in Device Packaging 1 1
Material Fragmentation 1 1
Peeled/Delaminated 1 1
Product Quality Problem 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Consequences Or Impact To Patient 107 107
No Clinical Signs, Symptoms or Conditions 51 51
No Known Impact Or Consequence To Patient 19 19
No Code Available 17 17
Foreign Body In Patient 8 8
Device Embedded In Tissue or Plaque 5 5
Insufficient Information 3 3
No Patient Involvement 3 3
Injury 1 1
Blood Loss 1 1
Abdominal Pain 1 1
Erosion 1 1
Inflammation 1 1
Necrosis 1 1
Perforation 1 1
Jaundice 1 1
Pancreatitis 1 1
Unspecified Hepatic or Biliary Problem 1 1

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