TPLC - Total Product Life Cycle

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Device	applier, surgical, clip
Regulation Description	Manual surgical instrument for general use.
Product Code	GDO
Regulation Number	878.4800
Device Class	1

Device Problems	MDRs with this Device Problem	Events in those MDRs
Failure to Form Staple	513	513
Mechanics Altered	304	304
Failure to Align	289	289
Failure to Fire	146	146
No Apparent Adverse Event	96	96
Mechanical Problem	92	92
Break	77	77
Mechanical Jam	67	67
Difficult to Open or Close	64	64
Detachment of Device or Device Component	52	52
Material Twisted/Bent	51	51
Activation, Positioning or Separation Problem	38	38
Appropriate Term/Code Not Available	32	32
Firing Problem	30	30
Adverse Event Without Identified Device or Use Problem	29	29
Insufficient Information	27	27
Material Integrity Problem	16	16
Entrapment of Device	15	15
Unintended Ejection	12	12
Loose or Intermittent Connection	12	12
Difficult to Remove	10	10
Misfire	10	10
Material Deformation	9	9
Delivered as Unsterile Product	9	9
Material Separation	9	9
Fail-Safe Problem	8	8
Manufacturing, Packaging or Shipping Problem	7	7
Patient Device Interaction Problem	6	6
Difficult to Open or Remove Packaging Material	5	5
Physical Resistance/Sticking	5	5
Separation Failure	5	5
Migration	5	5
Fracture	5	5
Positioning Problem	4	4
Activation Problem	4	4
Device Slipped	4	4
Product Quality Problem	3	3
Difficult to Insert	3	3
Difficult to Fold, Unfold or Collapse	3	3
Separation Problem	3	3
Leak/Splash	3	3
Defective Device	3	3
Therapeutic or Diagnostic Output Failure	3	3
Material Fragmentation	2	2
Activation Failure	2	2
Device Misassembled During Manufacturing /Shipping	2	2
Noise, Audible	2	2
Device Handling Problem	2	2
Use of Device Problem	2	2
Improper or Incorrect Procedure or Method	2	2

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	1259	1259
No Consequences Or Impact To Patient	152	152
Hemorrhage/Bleeding	107	107
Insufficient Information	51	51
Unspecified Tissue Injury	22	22
No Known Impact Or Consequence To Patient	13	13
Swelling/ Edema	8	8
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	8	8
Foreign Body In Patient	7	7
Perforation of Vessels	6	6
Cardiac Arrest	6	6
No Information	6	6
Pain	5	5
Exsanguination	5	5
Inflammation	5	5
Hematoma	4	4
Tissue Damage	3	3
Failure to Anastomose	3	3
Dyspnea	3	3
No Patient Involvement	3	3
Nerve Damage	2	2
Unintended Radiation Exposure	2	2
No Code Available	2	2
Laceration(s)	1	1
Pleural Effusion	1	1
Renal Failure	1	1
Wound Dehiscence	1	1
Abdominal Pain	1	1
Abscess	1	1
Adult Respiratory Distress Syndrome	1	1
Air Embolism	1	1
Fever	1	1
Unspecified Infection	1	1
Blood Loss	1	1
Tissue Breakdown	1	1
Unspecified Respiratory Problem	1	1