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	2262	2262
Shipping Damage or Problem	273	273
Failure to Fire	240	240
Failure to Align	185	185
Failure to Form Staple	146	146
Physical Resistance/Sticking	100	100
Delivered as Unsterile Product	98	98
Tear, Rip or Hole in Device Packaging	88	88
Misfire	80	80
Mechanical Problem	44	44
Firing Problem	42	42
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
Adverse Event Without Identified Device or Use Problem	14	14
Improper or Incorrect Procedure or Method	13	13
Use of Device Problem	11	11
Insufficient Information	10	10
Break	8	8
Packaging Problem	8	8
Material Deformation	8	8
Separation Failure	6	6
Unsealed Device Packaging	6	6
Material Twisted/Bent	6	6
Patient Device Interaction Problem	5	5
Device Fell	4	4
Defective Device	4	4
Material Separation	3	3
Patient-Device Incompatibility	3	3
Material Split, Cut or Torn	3	3
Mechanics Altered	2	2
Ejection Problem	2	2
Difficult to Remove	2	2
Defective Component	2	2
Unintended Movement	2	2
Nonstandard Device	2	2
Device Appears to Trigger Rejection	2	2
Premature Separation	2	2
Failure to Seal	2	2
Positioning Failure	1	1
Unraveled Material	1	1
Material Disintegration	1	1
Inadequacy of Device Shape and/or Size	1	1
No Apparent Adverse Event	1	1
Device Dislodged or Dislocated	1	1
Appropriate Term/Code Not Available	1	1
Crack	1	1
Difficult to Open or Remove Packaging Material	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	3081	3081
Insufficient Information	626	626
Wound Dehiscence	12	12
Skin Inflammation/ Irritation	10	10
Autoimmune Disorder	7	7
Hair Loss	6	6
Impaired Healing	5	5
Skin Tears	5	5
Post Operative Wound Infection	4	4
Abrasion	3	3
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	2	2
Foreign Body In Patient	2	2
Pain	2	2
Hemorrhage/Bleeding	2	2
Rash	1	1
Bacterial Infection	1	1