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	1187	1187
Break	627	627
Detachment of Device or Device Component	199	199
Material Separation	132	132
Material Deformation	131	131
Adverse Event Without Identified Device or Use Problem	130	130
Material Split, Cut or Torn	119	119
Fracture	119	119
Loss of or Failure to Bond	99	99
Material Twisted/Bent	67	67
Device Contaminated During Manufacture or Shipping	35	35
Deformation Due to Compressive Stress	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
Nonstandard Device	12	12
Difficult to Remove	12	12
Device Contamination with Chemical or Other Material	9	9
Tear, Rip or Hole in Device Packaging	8	8
Use of Device Problem	7	7
Contamination /Decontamination Problem	6	6
Appropriate Term/Code Not Available	6	6
Insufficient Information	6	6
Disconnection	5	5
Difficult to Advance	4	4
Physical Resistance/Sticking	4	4
Packaging Problem	4	4
Material Frayed	4	4
Device Damaged by Another Device	3	3
Activation, Positioning or Separation Problem	3	3
Sharp Edges	3	3
Component Misassembled	3	3
Entrapment of Device	3	3
Loose or Intermittent Connection	3	3
Component Missing	3	3
Off-Label Use	2	2
Peeled/Delaminated	2	2
Mechanical Problem	2	2
Device Handling Problem	2	2
Difficult to Insert	2	2
Defective Component	2	2
Device-Device Incompatibility	2	2
Contamination	1	1
Device Reprocessing Problem	1	1
Accessory Incompatible	1	1
Material Protrusion/Extrusion	1	1
Unintended Collision	1	1
Therapeutic or Diagnostic Output Failure	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	1948	1948
No Consequences Or Impact To Patient	355	355
Insufficient Information	112	112
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
Swelling/ Edema	5	5
No Code Available	5	5
Renal Failure	5	5
Abscess	3	3
Bacterial Infection	3	3
No Information	3	3
Unspecified Infection	3	3
Bowel Perforation	3	3
Obstruction/Occlusion	2	2
Vomiting	2	2
Urinary Retention	2	2
Septic Shock	2	2
Confusion/ Disorientation	2	2
Nausea	2	2
Respiratory Failure	1	1
Sleep Dysfunction	1	1
Choking	1	1
Abdominal Cramps	1	1
Fungal Infection	1	1
Injury	1	1
Anxiety	1	1
Urethral Stenosis/Stricture	1	1
Pancreatitis	1	1
Gastrointestinal Hemorrhage	1	1
Unspecified Respiratory Problem	1	1
Unspecified Immune System Problem	1	1
Unspecified Mental, Emotional or Behavioural Problem	1	1
Constipation	1	1
Multiple Organ Failure	1	1
Ambulation Difficulties	1	1
Tissue Breakdown	1	1
Abdominal Distention	1	1
Headache	1	1