TPLC - Total Product Life Cycle

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Device	dislodger, stone, basket, ureteral, metal
Regulation Description	Ureteral stone dislodger.
Product Code	FFL
Regulation Number	876.4680
Device Class	2

Device Problems	MDRs with this Device Problem	Events in those MDRs
Difficult to Open or Close	1180	1180
Break	708	709
Detachment of Device or Device Component	214	214
Adverse Event Without Identified Device or Use Problem	153	153
Loss of or Failure to Bond	142	143
Material Deformation	134	134
Material Split, Cut or Torn	115	115
Fracture	99	99
Material Separation	90	90
Material Twisted/Bent	63	63
Deformation Due to Compressive Stress	47	47
Material Fragmentation	29	29
Device Contaminated During Manufacture or Shipping	28	28
Device Damaged Prior to Use	27	27
Difficult to Fold, Unfold or Collapse	25	25
Nonstandard Device	18	18
Unsealed Device Packaging	16	16
Difficult to Remove	11	11
Tear, Rip or Hole in Device Packaging	9	9
Defective Device	8	8
Device Damaged by Another Device	7	7
Insufficient Information	6	6
Contamination /Decontamination Problem	6	6
Use of Device Problem	6	6
Disconnection	5	5
Difficult to Advance	5	5
Device Contamination with Chemical or Other Material	5	5
Component Misassembled	4	4
Packaging Problem	4	4
Sharp Edges	4	4
Material Frayed	3	3
Activation, Positioning or Separation Problem	3	3
Entrapment of Device	3	3
Loose or Intermittent Connection	3	3
Physical Resistance/Sticking	3	3
Appropriate Term/Code Not Available	3	3
Defective Component	3	3
Device Dislodged or Dislocated	2	2
Difficult to Insert	2	2
Peeled/Delaminated	2	2
Activation Problem	2	2
Mechanical Problem	2	2
Failure to Align	1	1
Component Missing	1	1
Material Rupture	1	1
Material Too Rigid or Stiff	1	1
Unraveled Material	1	1
Stretched	1	1
Microbial Contamination of Device	1	1
Incorrect Measurement	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	2321	2322
Insufficient Information	114	114
Foreign Body In Patient	74	75
No Consequences Or Impact To Patient	38	38
Urinary Tract Infection	30	30
Sepsis	20	20
Perforation	18	18
Pain	14	14
Hemorrhage/Bleeding	11	11
Hematuria	10	10
Fever	9	9
Laceration(s)	8	8
Unspecified Tissue Injury	7	7
Inflammation	6	6
Renal Failure	5	5
Swelling/ Edema	5	5
No Patient Involvement	4	4
Bowel Perforation	3	3
No Code Available	3	3
Device Embedded In Tissue or Plaque	3	3
Unspecified Infection	3	3
Abscess	3	3
Bacterial Infection	3	3
Nausea	2	2
Urinary Retention	2	2
Obstruction/Occlusion	2	2
No Information	2	2
Confusion/ Disorientation	2	2
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	2	2
Vomiting	2	2
Burning Sensation	1	1
Abdominal Distention	1	1
Tissue Breakdown	1	1
No Known Impact Or Consequence To Patient	1	1
Multiple Organ Failure	1	1
Constipation	1	1
Unspecified Mental, Emotional or Behavioural Problem	1	1
Unspecified Immune System Problem	1	1
Unspecified Respiratory Problem	1	1
Gastrointestinal Hemorrhage	1	1
Pancreatitis	1	1
Urethral Stenosis/Stricture	1	1
Localized Skin Lesion	1	1
Urinary Incontinence	1	1
Choking	1	1
Respiratory Failure	1	1
Sleep Dysfunction	1	1
Abdominal Cramps	1	1
Ambulation Difficulties	1	1
Rupture	1	1