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	524	524
Mechanics Altered	311	311
Failure to Align	304	304
Failure to Fire	148	148
No Apparent Adverse Event	98	98
Break	95	95
Mechanical Problem	95	95
Mechanical Jam	67	67
Difficult to Open or Close	67	67
Detachment of Device or Device Component	52	52
Material Twisted/Bent	52	52
Activation, Positioning or Separation Problem	38	38
Material Deformation	34	34
Appropriate Term/Code Not Available	32	32
Firing Problem	30	30
Adverse Event Without Identified Device or Use Problem	30	30
Insufficient Information	27	27
Material Integrity Problem	16	16
Entrapment of Device	15	15
Loose or Intermittent Connection	12	12
Unintended Ejection	12	12
Material Separation	10	10
Difficult to Remove	10	10
Delivered as Unsterile Product	10	10
Misfire	10	10
Fail-Safe Problem	8	8
Physical Resistance/Sticking	7	7
Manufacturing, Packaging or Shipping Problem	7	7
Device Slipped	6	6
Patient Device Interaction Problem	6	6
Difficult to Open or Remove Packaging Material	5	5
Separation Failure	5	5
Fracture	5	5
Migration	5	5
Activation Problem	4	4
Positioning Problem	4	4
Product Quality Problem	3	3
Difficult to Insert	3	3
Material Fragmentation	3	3
Therapeutic or Diagnostic Output Failure	3	3
Defective Device	3	3
Difficult to Fold, Unfold or Collapse	3	3
Separation Problem	3	3
Leak/Splash	3	3
Use of Device Problem	2	2
Device Misassembled During Manufacturing /Shipping	2	2
Ejection Problem	2	2
Device Handling Problem	2	2
Difficult or Delayed Separation	2	2
Activation Failure	2	2

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	1339	1339
No Consequences Or Impact To Patient	152	152
Hemorrhage/Bleeding	112	112
Insufficient Information	54	54
Unspecified Tissue Injury	22	22
No Known Impact Or Consequence To Patient	13	13
Foreign Body In Patient	10	10
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	8	8
Swelling/ Edema	8	8
No Information	6	6
Cardiac Arrest	6	6
Perforation of Vessels	6	6
Exsanguination	5	5
Inflammation	5	5
Pain	5	5
Hematoma	4	4
No Patient Involvement	3	3
Dyspnea	3	3
Failure to Anastomose	3	3
Tissue Damage	3	3
No Code Available	2	2
Nerve Damage	2	2
Unintended Radiation Exposure	2	2
Abdominal Pain	1	1
Air Embolism	1	1
Unspecified Infection	1	1
Wound Dehiscence	1	1
Adult Respiratory Distress Syndrome	1	1
Blood Loss	1	1
Fever	1	1
Pleural Effusion	1	1
Laceration(s)	1	1
Abscess	1	1
Renal Failure	1	1
Unspecified Respiratory Problem	1	1
Tissue Breakdown	1	1