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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 178 178

Device Problems MDRs with this Device Problem Events in those MDRs
Break 573 573
Material Deformation 146 146
Material Split, Cut or Torn 123 123
Detachment of Device or Device Component 121 121
Difficult to Open or Close 86 86
Separation Failure 81 81
Adverse Event Without Identified Device or Use Problem 59 59
Use of Device Problem 43 43
Difficult to Remove 35 35
Premature Activation 33 33
Material Twisted/Bent 17 17
Deformation Due to Compressive Stress 15 15
Mechanical Problem 14 14
Entrapment of Device 8 8
Material Separation 8 8
Mechanical Jam 7 7
Difficult to Advance 7 7
Defective Device 6 6
Appropriate Term/Code Not Available 6 6
Tear, Rip or Hole in Device Packaging 5 5
Accessory Incompatible 5 5
Leak/Splash 5 5
Retraction Problem 4 4
Fracture 3 3
Device-Device Incompatibility 3 3
Device Contamination with Chemical or Other Material 2 2
Device Reprocessing Problem 2 2
Crack 2 2
Problem with Sterilization 2 2
Device Damaged Prior to Use 2 2
Defective Component 2 2
Physical Resistance/Sticking 2 2
Separation Problem 1 1
Output Problem 1 1
Unintended Movement 1 1
Material Too Rigid or Stiff 1 1
Product Quality Problem 1 1
Unsealed Device Packaging 1 1
Device Dislodged or Dislocated 1 1
Material Integrity Problem 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 699 699
No Consequences Or Impact To Patient 220 220
No Code Available 42 42
Foreign Body In Patient 30 30
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 8 8
Pancreatitis 5 5
Unspecified Hepatic or Biliary Problem 4 4
Pain 3 3
Swelling/ Edema 2 2
Patient Problem/Medical Problem 2 2
Injury 2 2
No Patient Involvement 2 2
Pneumonia 2 2
Hypoxia 2 2
Inflammation 2 2
Fever 2 2
Hematoma 1 1
Low Blood Pressure/ Hypotension 1 1
Abdominal Pain 1 1
Bruise/Contusion 1 1
Death 1 1
Cardiac Enzyme Elevation 1 1
Myocardial Infarction 1 1
Unspecified Infection 1 1
Thrombosis 1 1
Thrombus 1 1
Tissue Damage 1 1
Vomiting 1 1
Intraoperative Pain 1 1
Bowel Perforation 1 1
Pseudoaneurysm 1 1
Peritonitis 1 1
Anxiety 1 1
Discomfort 1 1
No Information 1 1
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 1 1

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