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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
Regulation Description Mechanical lithotriptor.
Product CodeLQC
Regulation Number 876.4500
Device Class 2

MDR Year MDR Reports MDR Events
2020 164 164
2021 112 112
2022 245 245
2023 224 224
2024 301 301
2025 8 8

Device Problems MDRs with this Device Problem Events in those MDRs
Break 556 556
Material Split, Cut or Torn 141 141
Material Deformation 138 138
Detachment of Device or Device Component 126 126
Difficult to Open or Close 88 88
Adverse Event Without Identified Device or Use Problem 81 81
Separation Failure 68 68
Use of Device Problem 47 47
Difficult to Remove 32 32
Premature Activation 30 30
Material Twisted/Bent 18 18
Mechanical Problem 18 18
Deformation Due to Compressive Stress 14 14
Crack 11 11
Material Separation 8 8
Mechanical Jam 8 8
Difficult to Advance 7 7
Entrapment of Device 7 7
Appropriate Term/Code Not Available 6 6
Defective Device 6 6
Accessory Incompatible 5 5
Retraction Problem 5 5
Leak/Splash 5 5
Tear, Rip or Hole in Device Packaging 4 4
Defective Component 3 3
Material Integrity Problem 3 3
Device Damaged Prior to Use 2 2
Fracture 2 2
Physical Resistance/Sticking 2 2
Problem with Sterilization 2 2
Device Reprocessing Problem 2 2
Output Problem 1 1
Device-Device Incompatibility 1 1
Failure to Disconnect 1 1
Device Damaged by Another Device 1 1
Material Perforation 1 1
Unintended Movement 1 1
Separation Problem 1 1
Material Too Rigid or Stiff 1 1
Obstruction of Flow 1 1
Product Quality Problem 1 1
Device Dislodged or Dislocated 1 1
Unsealed Device Packaging 1 1
Device Contamination with Chemical or Other Material 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 823 823
No Consequences Or Impact To Patient 129 129
Foreign Body In Patient 31 31
No Code Available 26 26
Hemorrhage/Bleeding 17 17
No Known Impact Or Consequence To Patient 13 13
Perforation 10 10
Insufficient Information 9 9
Device Embedded In Tissue or Plaque 9 9
Pancreatitis 9 9
Abdominal Pain 5 5
Cardiac Arrest 4 4
Unspecified Hepatic or Biliary Problem 4 4
Pneumonia 4 4
Septic Shock 4 4
Fever 2 2
Hypoxia 2 2
Swelling/ Edema 2 2
Patient Problem/Medical Problem 2 2
Pain 2 2
Bradycardia 1 1
Bruise/Contusion 1 1
Death 1 1
Cardiac Enzyme Elevation 1 1
Low Blood Pressure/ Hypotension 1 1
Unspecified Infection 1 1
Inflammation 1 1
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 1 1
Pseudoaneurysm 1 1
Intraoperative Pain 1 1
Bowel Perforation 1 1
Myocardial Infarction 1 1
Tissue Damage 1 1
Vomiting 1 1
Peritonitis 1 1
Anxiety 1 1
Discomfort 1 1
Injury 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Aomori Olympus Co., Ltd. II Feb-05-2021
2 Olympus Corporation of the Americas II Jan-16-2025
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