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	590	592
Mechanics Altered	347	347
Failure to Align	342	342
Material Deformation	206	206
Failure to Fire	158	158
Break	158	158
Detachment of Device or Device Component	122	122
No Apparent Adverse Event	116	116
Mechanical Problem	96	96
Mechanical Jam	73	74
Difficult to Open or Close	61	61
Material Twisted/Bent	53	53
Adverse Event Without Identified Device or Use Problem	35	37
Activation, Positioning or Separation Problem	33	33
Firing Problem	30	30
Insufficient Information	24	24
Appropriate Term/Code Not Available	15	15
Entrapment of Device	15	15
Unintended Ejection	12	12
Material Integrity Problem	12	12
Loose or Intermittent Connection	12	12
Material Separation	10	10
Delivered as Unsterile Product	9	9
Device Slipped	8	8
Misfire	8	8
Separation Failure	7	7
Fail-Safe Problem	7	7
Physical Resistance/Sticking	7	7
Patient Device Interaction Problem	7	7
Failure to Seal	7	7
Defective Device	6	6
Product Quality Problem	5	5
Migration	5	5
Activation Problem	4	4
Therapeutic or Diagnostic Output Failure	4	4
Difficult to Remove	4	4
Device Dislodged or Dislocated	4	4
Fracture	4	4
Display or Visual Feedback Problem	3	3
Difficult to Fold, Unfold or Collapse	3	3
Use of Device Problem	3	3
Positioning Problem	3	3
Activation Failure	3	3
Noise, Audible	3	3
Separation Problem	3	3
Manufacturing, Packaging or Shipping Problem	3	3
Device Handling Problem	2	2
Output Problem	2	2
Difficult or Delayed Separation	2	2
Ejection Problem	2	2

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	1899	1902
Hemorrhage/Bleeding	139	139
Insufficient Information	63	63
Unspecified Tissue Injury	32	32
Foreign Body In Patient	9	9
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	8	8
Swelling/ Edema	8	10
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
Abdominal Distention	1	1
Pleural Effusion	1	1
Ecchymosis	1	1
Unspecified Respiratory Problem	1	1