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	1290	1290
Break	737	738
Detachment of Device or Device Component	229	229
Adverse Event Without Identified Device or Use Problem	155	155
Material Deformation	150	150
Material Separation	139	139
Material Split, Cut or Torn	126	126
Fracture	122	122
Loss of or Failure to Bond	121	122
Material Twisted/Bent	70	70
Deformation Due to Compressive Stress	46	46
Device Contaminated During Manufacture or Shipping	38	38
Difficult to Fold, Unfold or Collapse	36	36
Material Fragmentation	34	34
Device Damaged Prior to Use	32	32
Unsealed Device Packaging	17	17
Nonstandard Device	13	13
Defective Device	13	13
Difficult to Remove	12	12
Tear, Rip or Hole in Device Packaging	10	10
Use of Device Problem	10	10
Device Contamination with Chemical or Other Material	9	9
Device Damaged by Another Device	7	7
Contamination /Decontamination Problem	7	7
Appropriate Term/Code Not Available	6	6
Insufficient Information	6	6
Disconnection	5	5
Difficult to Advance	5	5
Component Misassembled	4	4
Packaging Problem	4	4
Physical Resistance/Sticking	4	4
Entrapment of Device	4	4
Material Frayed	4	4
Component Missing	3	3
Defective Component	3	3
Sharp Edges	3	3
Mechanical Problem	3	3
Loose or Intermittent Connection	3	3
Activation, Positioning or Separation Problem	3	3
Difficult to Insert	2	2
Device Handling Problem	2	2
Peeled/Delaminated	2	2
Off-Label Use	2	2
Device-Device Incompatibility	2	2
Microbial Contamination of Device	1	1
Stretched	1	1
Unraveled Material	1	1
Contamination	1	1
Material Too Rigid or Stiff	1	1
Failure to Align	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	2208	2209
No Consequences Or Impact To Patient	355	355
Insufficient Information	114	114
Foreign Body In Patient	76	77
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
Laceration(s)	8	8
Inflammation	8	8
Device Embedded In Tissue or Plaque	7	7
Unspecified Tissue Injury	7	7
No Code Available	5	5
Swelling/ Edema	5	5
Renal Failure	5	5
Unspecified Infection	3	3
Abscess	3	3
No Information	3	3
Bowel Perforation	3	3
Bacterial Infection	3	3
Urinary Retention	2	2
Vomiting	2	2
Septic Shock	2	2
Confusion/ Disorientation	2	2
Obstruction/Occlusion	2	2
Nausea	2	2
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	2	2
Extravasation	1	1
Anxiety	1	1
Anaphylactic Shock	1	1
Unspecified Respiratory Problem	1	1
Myocardial Infarction	1	1
Pneumonia	1	1
Constipation	1	1
Erosion	1	1
Choking	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