TPLC - Total Product Life Cycle

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

Device Problems	MDRs with this Device Problem	Events in those MDRs
Break	824	824
Material Deformation	315	315
Detachment of Device or Device Component	153	153
Separation Failure	134	134
Material Split, Cut or Torn	120	120
Difficult to Open or Close	89	89
Difficult to Remove	76	76
Adverse Event Without Identified Device or Use Problem	67	67
Use of Device Problem	45	45
Premature Activation	34	34
Detachment Of Device Component	30	30
Device Handling Problem	28	28
Material Twisted/Bent	19	19
Deformation Due to Compressive Stress	15	15
Mechanical Problem	14	14
Entrapment of Device	10	10
Defective Device	10	10
Device Operates Differently Than Expected	9	9
Material Separation	8	8
Tear, Rip or Hole in Device Packaging	7	7
Difficult to Advance	7	7
Mechanical Jam	6	6
Appropriate Term/Code Not Available	6	6
Fracture	5	5
Accessory Incompatible	5	5
Leak/Splash	5	5
Device-Device Incompatibility	4	4
Device Contamination with Chemical or Other Material	3	3
Physical Resistance/Sticking	2	2
Device Damaged Prior to Use	2	2
Defective Component	2	2
Retraction Problem	2	2
Crack	2	2
Device Reprocessing Problem	2	2
Problem with Sterilization	2	2
Sticking	2	2
Device Inoperable	2	2
Unsealed Device Packaging	2	2
Peeled/Delaminated	1	1
Off-Label Use	1	1
Product Quality Problem	1	1
Material Frayed	1	1
Material Too Rigid or Stiff	1	1
Improper or Incorrect Procedure or Method	1	1
Obstruction of Flow	1	1
Device Dislodged or Dislocated	1	1
Device Damaged by Another Device	1	1
Separation Problem	1	1
Output Problem	1	1
Torn Material	1	1
Unintended Movement	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Consequences Or Impact To Patient	714	714
No Clinical Signs, Symptoms or Conditions	665	665
No Known Impact Or Consequence To Patient	71	71
No Code Available	66	66
Foreign Body In Patient	38	38
Device Embedded In Tissue or Plaque	29	29
Hemorrhage/Bleeding	17	17
Injury	14	14
Perforation	13	13
Insufficient Information	8	8
No Patient Involvement	7	7
Pancreatitis	5	5
Unspecified Hepatic or Biliary Problem	4	4
No Information	4	4
Inflammation	4	4
Pain	4	4
Hypoxia	2	2
Fever	2	2
Pneumonia	2	2
Patient Problem/Medical Problem	2	2
Swelling/ Edema	2	2
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	1	1
Intraoperative Pain	1	1
Bowel Perforation	1	1
Pseudoaneurysm	1	1
Thrombosis	1	1
Thrombus	1	1
Tissue Damage	1	1
Peritonitis	1	1
Anxiety	1	1
Discomfort	1	1
Hematoma	1	1
Airway Obstruction	1	1
Bruise/Contusion	1	1
Death	1	1

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