TPLC - Total Product Life Cycle

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Device Problems	MDRs with this Device Problem	Events in those MDRs
Failure to Form Staple	560	575
Mechanics Altered	305	305
Failure to Align	278	278
Failure to Fire	150	150
Mechanical Problem	101	101
Difficult to Open or Close	97	97
Break	93	93
No Apparent Adverse Event	89	89
Mechanical Jam	76	76
Material Twisted/Bent	70	70
Detachment of Device or Device Component	69	69
Activation, Positioning or Separation Problem	46	46
Appropriate Term/Code Not Available	31	31
Firing Problem	30	30
Adverse Event Without Identified Device or Use Problem	29	29
Insufficient Information	27	27
Entrapment of Device	18	18
Material Integrity Problem	16	16
Device Fell	15	15
Leak/Splash	15	15
Loose or Intermittent Connection	14	14
Misfire	14	14
Unintended Ejection	12	12
Difficult to Remove	12	12
Defective Device	9	9
Material Separation	9	9
Physical Resistance/Sticking	9	9
Fail-Safe Problem	8	8
Device Slipped	8	8
Delivered as Unsterile Product	8	8
Material Deformation	8	8
Noise, Audible	7	7
Manufacturing, Packaging or Shipping Problem	6	6
Activation Problem	6	6
Patient Device Interaction Problem	6	6
Separation Failure	5	5
Positioning Problem	5	5
Therapeutic or Diagnostic Output Failure	5	5
Fracture	5	5
Difficult to Open or Remove Packaging Material	5	5
Separation Problem	5	5
Improper or Incorrect Procedure or Method	4	4
Corroded	4	4
Difficult to Fold, Unfold or Collapse	3	3
Difficult to Insert	3	3
Device Handling Problem	3	3
Product Quality Problem	3	3
Device Dislodged or Dislocated	2	2
Failure to Advance	2	2
Packaging Problem	2	2

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	1148	1148
No Consequences Or Impact To Patient	407	422
Hemorrhage/Bleeding	97	97
Insufficient Information	47	47
No Known Impact Or Consequence To Patient	36	36
Unspecified Tissue Injury	21	21
No Information	9	9
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	8	8
Swelling/ Edema	8	8
No Code Available	7	7
Foreign Body In Patient	7	7
Perforation of Vessels	7	7
Inflammation	5	5
No Patient Involvement	5	5
Pain	5	5
Tissue Damage	5	5
Hematoma	4	4
Cardiac Arrest	4	4
Blood Loss	3	3
Dyspnea	3	3
Nerve Damage	2	2
Laceration(s)	2	2
Failure to Anastomose	2	2
Unintended Radiation Exposure	2	2
Abdominal Pain	1	1
Unspecified Infection	1	1
Patient Problem/Medical Problem	1	1
Wound Dehiscence	1	1
Adult Respiratory Distress Syndrome	1	1
Exsanguination	1	1
Fever	1	1
Pleural Effusion	1	1
Hemostasis	1	1
Abscess	1	1
Renal Failure	1	1
Tissue Breakdown	1	1
Device Embedded In Tissue or Plaque	1	1