TPLC - Total Product Life Cycle

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Device	stapler, skin
Regulation Description	Surgical stapler.
Definition	A surgical stapler for external use is a specialized prescription device used to deliver compatible staples to skin during surgery.
Product Code	QQS
Regulation Number	878.4740
Device Class	1

Device Problems	MDRs with this Device Problem	Events in those MDRs
Mechanical Jam	2196	2196
Shipping Damage or Problem	272	272
Failure to Fire	216	216
Failure to Align	183	183
Failure to Form Staple	133	133
Physical Resistance/Sticking	99	99
Delivered as Unsterile Product	88	88
Tear, Rip or Hole in Device Packaging	88	88
Misfire	80	80
Mechanical Problem	44	44
Firing Problem	40	40
Difficult to Open or Close	30	30
Detachment of Device or Device Component	19	19
Manufacturing, Packaging or Shipping Problem	17	17
Material Integrity Problem	16	16
Unintended Ejection	16	16
Improper or Incorrect Procedure or Method	13	13
Use of Device Problem	11	11
Insufficient Information	10	10
Packaging Problem	8	8
Break	8	8
Adverse Event Without Identified Device or Use Problem	7	7
Separation Failure	6	6
Material Deformation	6	6
Material Twisted/Bent	4	4
Defective Device	4	4
Patient Device Interaction Problem	4	4
Unsealed Device Packaging	4	4
Material Split, Cut or Torn	3	3
Material Separation	3	3
Device Fell	3	3
Premature Separation	2	2
Difficult to Remove	2	2
Nonstandard Device	2	2
Defective Component	2	2
Mechanics Altered	2	2
Patient-Device Incompatibility	2	2
Ejection Problem	2	2
Device Appears to Trigger Rejection	2	2
Unintended Movement	1	1
Failure to Seal	1	1
Crack	1	1
Material Disintegration	1	1
Positioning Failure	1	1
No Apparent Adverse Event	1	1
Difficult to Open or Remove Packaging Material	1	1
Unraveled Material	1	1
Inadequacy of Device Shape and/or Size	1	1
Device Dislodged or Dislocated	1	1
Activation, Positioning or Separation Problem	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	2988	2988
Insufficient Information	609	609
Skin Inflammation/ Irritation	9	9
Autoimmune Disorder	7	7
Skin Tears	5	5
Impaired Healing	5	5
Wound Dehiscence	4	4
Hair Loss	4	4
Abrasion	3	3
Post Operative Wound Infection	3	3
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	2	2
Foreign Body In Patient	2	2
Pain	2	2
Bacterial Infection	1	1
Hemorrhage/Bleeding	1	1