TPLC - Total Product Life Cycle

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Device	punch, surgical
Regulation Description	Manual surgical instrument for general use.
Product Code	LRY
Regulation Number	878.4800
Device Class	1

Device Problems	MDRs with this Device Problem	Events in those MDRs
Break	58	58
Material Twisted/Bent	32	32
Packaging Problem	28	29
Device-Device Incompatibility	24	24
Contamination /Decontamination Problem	20	20
Dull, Blunt	20	29
Material Deformation	17	17
Failure to Cut	12	13
Naturally Worn	12	12
Mechanical Problem	11	12
Physical Resistance/Sticking	11	11
Material Integrity Problem	9	9
Material Fragmentation	9	9
Mechanical Jam	7	7
Compatibility Problem	4	4
Device Contaminated During Manufacture or Shipping	4	4
Manufacturing, Packaging or Shipping Problem	4	4
Sharp Edges	3	3
Material Too Soft/Flexible	3	3
Off-Label Use	2	2
Unintended Movement	2	2
Therapeutic or Diagnostic Output Failure	2	2
Use of Device Problem	2	2
Adverse Event Without Identified Device or Use Problem	2	2
Fracture	2	2
Loose or Intermittent Connection	2	2
Device Slipped	1	1
Crack	1	1
Difficult to Remove	1	1
Degraded	1	1
Component Missing	1	1
Difficult or Delayed Separation	1	1
Product Quality Problem	1	1
Detachment of Device or Device Component	1	1
No Apparent Adverse Event	1	1
Improper or Incorrect Procedure or Method	1	1
Deformation Due to Compressive Stress	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	224	226
Insufficient Information	18	18
Perforation of Vessels	12	21
Laceration(s)	3	3
Unspecified Tissue Injury	3	3
Intraoperative Pain	1	1
Abrasion	1	1
Needle Stick/Puncture	1	1
Great Vessel Perforation	1	1
Skin Tears	1	1
Hemorrhage/Bleeding	1	1