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	557	557
Material Split, Cut or Torn	148	148
Material Deformation	143	143
Detachment of Device or Device Component	124	124
Adverse Event Without Identified Device or Use Problem	119	119
Difficult to Open or Close	96	96
Use of Device Problem	63	63
Separation Failure	57	57
Difficult to Remove	34	34
Premature Activation	33	33
Material Twisted/Bent	20	20
Mechanical Problem	15	15
Deformation Due to Compressive Stress	15	15
Crack	11	11
Mechanical Jam	10	10
Entrapment of Device	9	9
Material Separation	8	8
Difficult to Advance	8	8
Separation Problem	6	6
Defective Device	6	6
Leak/Splash	5	5
Accessory Incompatible	5	5
Retraction Problem	5	5
Tear, Rip or Hole in Device Packaging	4	4
Defective Component	3	3
Physical Resistance/Sticking	3	3
Material Integrity Problem	3	3
No Apparent Adverse Event	2	2
Device Damaged Prior to Use	2	2
Problem with Sterilization	2	2
Fracture	2	2
Device Reprocessing Problem	2	2
Difficult or Delayed Positioning	1	1
Difficult to Fold, Unfold or Collapse	1	1
Material Too Rigid or Stiff	1	1
Off-Label Use	1	1
Nonstandard Device	1	1
Unintended System Motion	1	1
Unsealed Device Packaging	1	1
Material Perforation	1	1
Failure to Disconnect	1	1
Device Dislodged or Dislocated	1	1
Device Contamination with Chemical or Other Material	1	1
Device Damaged by Another Device	1	1
Device-Device Incompatibility	1	1
Output Problem	1	1
Unintended Movement	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	988	988
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	4	4
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