TPLC - Total Product Life Cycle

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Device	lithotriptor, biliary mechanical
Regulation Description	Mechanical lithotriptor.
Product Code	LQC
Regulation Number	876.4500
Device Class	2

Device Problems	MDRs with this Device Problem	Events in those MDRs
Break	567	567
Material Split, Cut or Torn	155	155
Material Deformation	143	143
Detachment of Device or Device Component	124	124
Adverse Event Without Identified Device or Use Problem	122	122
Difficult to Open or Close	98	98
Use of Device Problem	69	69
Separation Failure	60	60
Difficult to Remove	36	36
Premature Activation	33	33
Material Twisted/Bent	21	21
Deformation Due to Compressive Stress	15	15
Mechanical Problem	15	15
Mechanical Jam	11	11
Crack	11	11
Entrapment of Device	9	9
Material Separation	8	8
Difficult to Advance	8	8
Defective Device	6	6
Separation Problem	6	6
Accessory Incompatible	5	5
Retraction Problem	5	5
Leak/Splash	5	5
Tear, Rip or Hole in Device Packaging	4	4
Material Integrity Problem	3	3
Defective Component	3	3
Physical Resistance/Sticking	3	3
Problem with Sterilization	2	2
Device Damaged Prior to Use	2	2
No Apparent Adverse Event	2	2
Fracture	2	2
Device Reprocessing Problem	2	2
Unsealed Device Packaging	1	1
Unintended Movement	1	1
Material Too Rigid or Stiff	1	1
Difficult to Fold, Unfold or Collapse	1	1
Material Perforation	1	1
Failure to Cut	1	1
Device Damaged by Another Device	1	1
Difficult or Delayed Positioning	1	1
Output Problem	1	1
Device Contamination with Chemical or Other Material	1	1
Device Dislodged or Dislocated	1	1
Nonstandard Device	1	1
Unintended System Motion	1	1
Off-Label Use	1	1
Failure to Disconnect	1	1
Device-Device Incompatibility	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	1004	1004
Foreign Body In Patient	33	33
Perforation	11	11
Pancreatitis	10	10
Hemorrhage/Bleeding	10	10
Insufficient Information	9	9
No Consequences Or Impact To Patient	8	8
Device Embedded In Tissue or Plaque	8	8
Abdominal Pain	5	5
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	5	5
Cardiac Arrest	4	4
Septic Shock	4	4
Unspecified Hepatic or Biliary Problem	4	4
Pneumonia	4	4
No Code Available	2	2
Fever	2	2
Pain	2	2
Swelling/ Edema	2	2
Hypoxia	2	2
Unspecified Infection	1	1
Intraoperative Pain	1	1
Gastrointestinal Hemorrhage	1	1
Bowel Perforation	1	1
Peritonitis	1	1
Vomiting	1	1
Discomfort	1	1
Bradycardia	1	1
Anxiety	1	1
Myocardial Infarction	1	1
Pseudoaneurysm	1	1
Cardiac Enzyme Elevation	1	1
Low Blood Pressure/ Hypotension	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