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	539	541
Failure to Align	327	327
Mechanics Altered	307	307
Material Deformation	203	203
Break	150	150
Failure to Fire	145	145
No Apparent Adverse Event	114	114
Mechanical Problem	78	78
Mechanical Jam	71	72
Difficult to Open or Close	59	59
Material Twisted/Bent	51	51
Detachment of Device or Device Component	46	46
Activation, Positioning or Separation Problem	33	33
Adverse Event Without Identified Device or Use Problem	33	35
Firing Problem	29	29
Insufficient Information	23	23
Appropriate Term/Code Not Available	15	15
Entrapment of Device	14	14
Loose or Intermittent Connection	12	12
Unintended Ejection	12	12
Material Integrity Problem	12	12
Material Separation	10	10
Misfire	8	8
Delivered as Unsterile Product	7	7
Fail-Safe Problem	7	7
Physical Resistance/Sticking	7	7
Device Slipped	7	7
Patient Device Interaction Problem	6	6
Separation Failure	6	6
Failure to Seal	6	6
Defective Device	5	5
Migration	5	5
Product Quality Problem	5	5
Difficult to Remove	4	4
Fracture	4	4
Activation Problem	4	4
Therapeutic or Diagnostic Output Failure	3	3
Device Dislodged or Dislocated	3	3
Positioning Problem	3	3
Manufacturing, Packaging or Shipping Problem	3	3
Use of Device Problem	3	3
Difficult to Fold, Unfold or Collapse	3	3
Separation Problem	3	3
Activation Failure	2	2
Improper or Incorrect Procedure or Method	2	2
Noise, Audible	2	2
Difficult or Delayed Separation	2	2
Device Handling Problem	2	2
Material Rupture	2	2
Dent in Material	2	2

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	1699	1702
Hemorrhage/Bleeding	134	134
Insufficient Information	58	58
Unspecified Tissue Injury	26	26
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
Perforation of Vessels	6	6
Exsanguination	5	7
Inflammation	5	5
Pain	5	5
Hematoma	4	4
Dyspnea	3	5
Nerve Damage	2	2
Failure to Anastomose	2	2
Unintended Radiation Exposure	2	2
Air Embolism	1	1
Unspecified Infection	1	1
Wound Dehiscence	1	1
Adult Respiratory Distress Syndrome	1	1
Pleural Effusion	1	1
Ecchymosis	1	1
Laceration(s)	1	1
Unspecified Respiratory Problem	1	1
Tissue Breakdown	1	1