TPLC - Total Product Life Cycle

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Device	bit, surgical
Regulation Description	Surgical instrument motors and accessories/attachments.
Product Code	GFG
Regulation Number	878.4820
Device Class	1

Device Problems	MDRs with this Device Problem	Events in those MDRs
Break	241	243
Fracture	153	154
Material Fragmentation	30	30
Entrapment of Device	15	15
Failure to Cut	13	13
Mechanical Jam	11	11
Material Deformation	8	8
Device-Device Incompatibility	7	7
Contamination /Decontamination Problem	5	5
Delivered as Unsterile Product	5	5
Residue After Decontamination	5	5
Physical Resistance/Sticking	4	4
Insufficient Information	4	4
Material Twisted/Bent	4	4
Detachment of Device or Device Component	4	4
Adverse Event Without Identified Device or Use Problem	3	3
Material Integrity Problem	2	2
Use of Device Problem	2	2
Difficult to Open or Close	2	2
Firing Problem	2	2
Unstable	1	1
Material Split, Cut or Torn	1	1
Mechanical Problem	1	3
Crack	1	1
Device Markings/Labelling Problem	1	1
Material Erosion	1	1
Difficult to Remove	1	1
Scratched Material	1	1
Positioning Failure	1	1
Material Discolored	1	1
Device Difficult to Setup or Prepare	1	1
Component Missing	1	1
Misassembled	1	1
Material Separation	1	1
Failure to Fire	1	1
No Apparent Adverse Event	1	1
Device Dislodged or Dislocated	1	1
Failure to Cycle	1	1
Improper or Incorrect Procedure or Method	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	341	342
Insufficient Information	36	38
Foreign Body In Patient	29	29
Device Embedded In Tissue or Plaque	11	12
Metal Related Pathology	2	2
Failure of Implant	1	1
Perforation	1	1
Unspecified Tissue Injury	1	1