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	1174	1174
Break	608	608
Detachment of Device or Device Component	196	196
Material Separation	129	129
Material Deformation	129	129
Adverse Event Without Identified Device or Use Problem	129	129
Fracture	118	118
Material Split, Cut or Torn	117	117
Loss of or Failure to Bond	98	98
Material Twisted/Bent	65	65
Deformation Due to Compressive Stress	34	34
Device Contaminated During Manufacture or Shipping	34	34
Difficult to Fold, Unfold or Collapse	33	33
Material Fragmentation	31	31
Device Damaged Prior to Use	29	29
Unsealed Device Packaging	14	14
Defective Device	13	13
Difficult to Remove	12	12
Nonstandard Device	11	11
Device Contamination with Chemical or Other Material	9	9
Tear, Rip or Hole in Device Packaging	8	8
Use of Device Problem	7	7
Appropriate Term/Code Not Available	6	6
Insufficient Information	6	6
Contamination /Decontamination Problem	6	6
Disconnection	5	5
Material Frayed	4	4
Physical Resistance/Sticking	4	4
Difficult to Advance	4	4
Packaging Problem	4	4
Loose or Intermittent Connection	3	3
Component Misassembled	3	3
Sharp Edges	3	3
Device Damaged by Another Device	3	3
Component Missing	3	3
Entrapment of Device	3	3
Activation, Positioning or Separation Problem	3	3
Difficult to Insert	2	2
Device Handling Problem	2	2
Defective Component	2	2
Peeled/Delaminated	2	2
Off-Label Use	2	2
Mechanical Problem	2	2
Device-Device Incompatibility	2	2
Unraveled Material	1	1
Material Too Rigid or Stiff	1	1
Failure to Align	1	1
Stretched	1	1
Microbial Contamination of Device	1	1
Contamination	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	1906	1906
No Consequences Or Impact To Patient	355	355
Insufficient Information	111	111
Foreign Body In Patient	70	70
No Known Impact Or Consequence To Patient	41	41
Urinary Tract Infection	30	30
Sepsis	20	20
Perforation	19	19
No Patient Involvement	16	16
Pain	14	14
Hemorrhage/Bleeding	11	11
Hematuria	10	10
Fever	9	9
Inflammation	8	8
Device Embedded In Tissue or Plaque	7	7
Unspecified Tissue Injury	7	7
Laceration(s)	6	6
No Code Available	5	5
Swelling/ Edema	5	5
Renal Failure	5	5
Unspecified Infection	3	3
Bacterial Infection	3	3
No Information	3	3
Bowel Perforation	3	3
Abscess	3	3
Urinary Retention	2	2
Vomiting	2	2
Nausea	2	2
Septic Shock	2	2
Obstruction/Occlusion	2	2
Confusion/ Disorientation	2	2
Choking	1	1
Pneumonia	1	1
Anaphylactic Shock	1	1
Extravasation	1	1
Anxiety	1	1
Unspecified Respiratory Problem	1	1
Myocardial Infarction	1	1
Constipation	1	1
Erosion	1	1
Headache	1	1
Respiratory Failure	1	1
Tissue Breakdown	1	1
Fistula	1	1
Ambulation Difficulties	1	1
Diarrhea	1	1
Burning Sensation	1	1
Unspecified Mental, Emotional or Behavioural Problem	1	1
Injury	1	1
Autoimmune Disorder	1	1