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	684	684
Mechanics Altered	390	390
Failure to Align	354	354
Failure to Fire	220	220
Material Deformation	208	208
No Apparent Adverse Event	170	170
Break	167	167
Detachment of Device or Device Component	131	131
Mechanical Problem	103	103
Device Dislodged or Dislocated	85	85
Mechanical Jam	69	69
Difficult to Open or Close	68	68
Material Twisted/Bent	55	55
Adverse Event Without Identified Device or Use Problem	34	34
Activation, Positioning or Separation Problem	31	31
Firing Problem	29	29
Insufficient Device Problem Information	25	25
Entrapment of Device	17	17
Appropriate Device Problem Term/Code Not Available	16	16
Loose or Intermittent Connection	12	12
Material Integrity Problem	12	12
Unintended Ejection	12	12
Delivered as Unsterile Product	11	11
Device Slipped	11	11
Material Separation	10	10
Failure to Seal	8	8
Fail-Safe Problem	8	8
Patient Device Interaction Problem	7	7
Difficult to Remove	6	6
Fracture	6	6
Separation Failure	6	6
Noise, Audible	5	5
Physical Resistance/Sticking	5	5
Migration	5	5
Product Quality Problem	5	5
Display or Visual Feedback Problem	4	4
Difficult to Insert	3	3
Device Misassembled During Manufacturing /Shipping	3	3
Separation Problem	3	3
Positioning Problem	3	3
Manufacturing, Packaging or Shipping Problem	3	3
Activation Problem	3	3
Difficult to Fold, Unfold or Collapse	3	3
Improper or Incorrect Procedure or Method	2	2
Nonstandard Device	2	2
Difficult or Delayed Separation	2	2
Device Handling Problem	2	2
Material Rupture	2	2
Dent in Material	2	2
Use of Device Problem	2	2

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	2163	2166
Hemorrhage/Blood Loss/Bleeding	194	194
Insufficient Information	65	65
Unspecified Tissue Injury	42	42
Foreign Body In Patient	12	12
Swelling/ Edema	8	10
Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available	8	8
Cardiac Arrest	6	8
Pain	6	6
Perforation of Vessels	6	6
Exsanguination	5	7
Inflammation	5	5
Hematoma	4	4
Dyspnea	3	5
Tissue Breakdown	3	3
Nerve Damage	2	2
Laceration(s)	2	2
Failure to Anastomose	2	2
Unintended Radiation Exposure	2	2
Air Embolism	1	1
Unspecified Infection	1	1
Wound Dehiscence	1	1
Hypersensitivity/Allergic reaction	1	1
Adult Respiratory Distress Syndrome	1	1
Vascular Dissection	1	1
Abdominal Distention	1	1
Pleural Effusion	1	1
Ecchymosis	1	1
Unspecified Respiratory Problem	1	1