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	619	619
Material Split, Cut or Torn	150	150
Material Deformation	144	144
Detachment of Device or Device Component	134	134
Adverse Event Without Identified Device or Use Problem	109	109
Difficult to Open or Close	96	96
Separation Failure	73	73
Use of Device Problem	54	54
Difficult to Remove	34	34
Premature Activation	33	33
Material Twisted/Bent	20	20
Mechanical Problem	18	18
Deformation Due to Compressive Stress	15	15
Crack	11	11
Mechanical Jam	9	9
Entrapment of Device	8	8
Defective Device	8	8
Material Separation	8	8
Difficult to Advance	7	7
Separation Problem	6	6
Appropriate Term/Code Not Available	6	6
Leak/Splash	5	5
Accessory Incompatible	5	5
Retraction Problem	5	5
Tear, Rip or Hole in Device Packaging	4	4
Physical Resistance/Sticking	3	3
Defective Component	3	3
Material Integrity Problem	3	3
Device Reprocessing Problem	2	2
Fracture	2	2
Problem with Sterilization	2	2
Device Damaged Prior to Use	2	2
Difficult or Delayed Positioning	1	1
Device Damaged by Another Device	1	1
Material Perforation	1	1
Obstruction of Flow	1	1
Product Quality Problem	1	1
Device Contamination with Chemical or Other Material	1	1
Material Too Rigid or Stiff	1	1
Device Dislodged or Dislocated	1	1
Unsealed Device Packaging	1	1
Unintended Movement	1	1
Difficult to Fold, Unfold or Collapse	1	1
Failure to Disconnect	1	1
Output Problem	1	1
Device-Device Incompatibility	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	924	924
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
Pancreatitis	10	10
Perforation	10	10
Insufficient Information	10	10
Device Embedded In Tissue or Plaque	9	9
Abdominal Pain	5	5
Cardiac Arrest	4	4
Septic Shock	4	4
Unspecified Hepatic or Biliary Problem	4	4
Pneumonia	4	4
Patient Problem/Medical Problem	2	2
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	2	2
Fever	2	2
Pain	2	2
Swelling/ Edema	2	2
Hypoxia	2	2
Unspecified Infection	1	1
Death	1	1
Intraoperative Pain	1	1
Gastrointestinal Hemorrhage	1	1
Bowel Perforation	1	1
Inflammation	1	1
Peritonitis	1	1
Injury	1	1
Vomiting	1	1
Discomfort	1	1
Bradycardia	1	1
Anxiety	1	1
Myocardial Infarction	1	1
Tissue Damage	1	1
Pseudoaneurysm	1	1
Cardiac Enzyme Elevation	1	1
Low Blood Pressure/ Hypotension	1	1
Bruise/Contusion	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