TPLC - Total Product Life Cycle

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Device	stapler, skin
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	1262	1262
Shipping Damage or Problem	196	196
Failure to Fire	129	129
Failure to Align	123	123
Failure to Form Staple	87	87
Delivered as Unsterile Product	70	70
Tear, Rip or Hole in Device Packaging	69	69
Physical Resistance/Sticking	44	44
Misfire	26	26
Difficult to Open or Close	23	23
Unintended Ejection	15	15
Detachment of Device or Device Component	13	13
Firing Problem	11	11
Use of Device Problem	10	10
Improper or Incorrect Procedure or Method	10	10
Adverse Event Without Identified Device or Use Problem	7	7
Packaging Problem	7	7
Mechanical Problem	6	6
Material Deformation	5	5
Material Integrity Problem	5	5
Insufficient Information	4	4
Break	3	3
Material Twisted/Bent	3	3
Patient-Device Incompatibility	2	2
Ejection Problem	2	2
Premature Separation	2	2
Mechanics Altered	2	2
Material Separation	2	2
Separation Failure	1	1
Unintended Movement	1	1
Crack	1	1
Difficult to Open or Remove Packaging Material	1	1
Defective Component	1	1
Failure to Seal	1	1
Unraveled Material	1	1
Appropriate Term/Code Not Available	1	1
Device Dislodged or Dislocated	1	1
Activation, Positioning or Separation Problem	1	1
No Apparent Adverse Event	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	1718	1718
Insufficient Information	391	391
Autoimmune Disorder	7	7
Skin Inflammation/ Irritation	6	6
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	2	2
Foreign Body In Patient	2	2
Wound Dehiscence	1	1
Bacterial Infection	1	1
Hemorrhage/Bleeding	1	1
Pain	1	1
Impaired Healing	1	1
Post Operative Wound Infection	1	1
Skin Tears	1	1