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	593	595
Mechanics Altered	339	339
Failure to Align	327	327
Material Deformation	172	172
Failure to Fire	157	157
Break	148	148
No Apparent Adverse Event	115	115
Mechanical Problem	105	105
Difficult to Open or Close	80	80
Mechanical Jam	74	75
Material Twisted/Bent	57	57
Detachment of Device or Device Component	54	54
Activation, Positioning or Separation Problem	38	38
Appropriate Term/Code Not Available	36	36
Firing Problem	34	34
Adverse Event Without Identified Device or Use Problem	34	36
Insufficient Information	27	27
Material Integrity Problem	16	16
Entrapment of Device	15	15
Loose or Intermittent Connection	12	12
Unintended Ejection	12	12
Difficult to Remove	11	11
Material Separation	11	11
Delivered as Unsterile Product	11	11
Misfire	10	10
Fail-Safe Problem	8	8
Device Slipped	7	7
Physical Resistance/Sticking	7	7
Separation Failure	7	7
Manufacturing, Packaging or Shipping Problem	7	7
Failure to Seal	6	6
Patient Device Interaction Problem	6	6
Difficult to Open or Remove Packaging Material	5	5
Fracture	5	5
Defective Device	5	5
Migration	5	5
Product Quality Problem	5	5
Activation Problem	4	4
Positioning Problem	4	4
Device Dislodged or Dislocated	3	3
Use of Device Problem	3	3
Therapeutic or Diagnostic Output Failure	3	3
Difficult to Fold, Unfold or Collapse	3	3
Separation Problem	3	3
Leak/Splash	3	3
Dent in Material	2	2
Material Rupture	2	2
Device Misassembled During Manufacturing /Shipping	2	2
Device Handling Problem	2	2
Difficult or Delayed Separation	2	2

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	1679	1682
No Consequences Or Impact To Patient	152	152
Hemorrhage/Bleeding	132	132
Insufficient Information	60	60
Unspecified Tissue Injury	26	26
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	10
No Information	6	6
Cardiac Arrest	6	8
Perforation of Vessels	6	6
Exsanguination	5	7
Inflammation	5	5
Pain	5	5
Hematoma	4	4
No Patient Involvement	3	3
Dyspnea	3	5
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
Ecchymosis	1	1
Laceration(s)	1	1
Abscess	1	1
Renal Failure	1	1
Unspecified Respiratory Problem	1	1
Tissue Breakdown	1	1