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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device lithotriptor, biliary mechanical
Product CodeLQC
Regulation Number 876.4500
Device Class 2

MDR Year MDR Reports MDR Events
2019 123 123
2020 164 164
2021 112 112
2022 245 245
2023 224 224
2024 92 92

Device Problems MDRs with this Device Problem Events in those MDRs
Break 528 528
Material Deformation 142 142
Detachment of Device or Device Component 115 115
Material Split, Cut or Torn 98 98
Difficult to Open or Close 85 85
Separation Failure 81 81
Adverse Event Without Identified Device or Use Problem 56 56
Use of Device Problem 40 40
Difficult to Remove 32 32
Premature Activation 31 31
Material Twisted/Bent 17 17
Deformation Due to Compressive Stress 15 15
Mechanical Problem 14 14
Material Separation 8 8
Entrapment of Device 7 7
Difficult to Advance 7 7
Mechanical Jam 6 6
Defective Device 6 6
Appropriate Term/Code Not Available 6 6
Accessory Incompatible 5 5
Leak/Splash 4 4
Fracture 3 3
Tear, Rip or Hole in Device Packaging 3 3
Device-Device Incompatibility 3 3
Device Contamination with Chemical or Other Material 2 2
Device Reprocessing Problem 2 2
Problem with Sterilization 2 2
Defective Component 2 2
Physical Resistance/Sticking 2 2
Separation Problem 1 1
Device Damaged Prior to Use 1 1
Material Too Rigid or Stiff 1 1
Crack 1 1
Product Quality Problem 1 1
Device Dislodged or Dislocated 1 1
Output Problem 1 1
Unintended Movement 1 1
Device Damaged by Another Device 1 1
Obstruction of Flow 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 617 617
No Consequences Or Impact To Patient 220 220
No Code Available 42 42
Foreign Body In Patient 29 29
No Known Impact Or Consequence To Patient 18 18
Hemorrhage/Bleeding 16 16
Device Embedded In Tissue or Plaque 13 13
Perforation 8 8
Insufficient Information 7 7
Pancreatitis 5 5
Pain 3 3
Unspecified Hepatic or Biliary Problem 2 2
Swelling/ Edema 2 2
Patient Problem/Medical Problem 2 2
No Patient Involvement 2 2
Pneumonia 2 2
Hypoxia 2 2
Inflammation 2 2
Injury 2 2
Pseudoaneurysm 1 1
Peritonitis 1 1
Anxiety 1 1
Discomfort 1 1
Thrombosis 1 1
Thrombus 1 1
Tissue Damage 1 1
Bruise/Contusion 1 1
Death 1 1
Fever 1 1
Hematoma 1 1
Intraoperative Pain 1 1
Bowel Perforation 1 1
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 1 1
No Information 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Aomori Olympus Co., Ltd. II Feb-05-2021
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