TPLC - Total Product Life Cycle

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Device Problems	MDRs with this Device Problem	Events in those MDRs
Excessive Heating	1910	1910
Vibration	599	599
Device Damaged by Another Device	426	426
Detachment of Device or Device Component	295	295
Overheating of Device	264	264
Complete Loss of Power	263	263
Unintended System Motion	252	252
Device Alarm System	203	203
Noise, Audible	180	180
Break	161	161
Device-Device Incompatibility	147	147
Fail-Safe Did Not Operate	129	129
Appropriate Term/Code Not Available	111	111
Material Fragmentation	107	107
Mechanical Jam	58	58
Material Frayed	49	49
Separation Problem	43	43
Leak/Splash	41	41
Output below Specifications	38	38
Fail-Safe Problem	33	33
Difficult or Delayed Separation	32	32
Premature Separation	31	31
Device Slipped	24	24
Mechanical Problem	23	23
No Apparent Adverse Event	20	20
Environmental Particulates	17	17
Loss of Power	14	14
Device Reprocessing Problem	14	14
Corroded	13	13
Fluid/Blood Leak	11	11
Electrical /Electronic Property Problem	11	11
Component Missing	10	10
Intermittent Loss of Power	8	8
Adverse Event Without Identified Device or Use Problem	8	8
Dull, Blunt	7	7
Device Markings/Labelling Problem	7	7
Difficult to Insert	6	6
Physical Resistance/Sticking	6	6
Connection Problem	6	6
Unintended Movement	6	6
Difficult to Remove	5	5
Separation Failure	5	5
Device Remains Activated	4	4
Manufacturing, Packaging or Shipping Problem	4	4
Material Rupture	4	4
Material Deformation	4	4
Naturally Worn	4	4
Fracture	4	4
Component or Accessory Incompatibility	3	3
Degraded	3	3

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	2903	2903
No Consequences Or Impact To Patient	1114	1114
No Known Impact Or Consequence To Patient	44	44
Insufficient Information	18	18
Burn(s)	13	13
Unspecified Tissue Injury	5	5
Brain Injury	3	3
Burn, Thermal	3	3
Full thickness (Third Degree) Burn	3	3
Superficial (First Degree) Burn	2	2
Perforation	2	2
Injury	2	2
Foreign Body In Patient	2	2
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	1	1
No Code Available	1	1
Chemical Exposure	1	1
Post Traumatic Wound Infection	1	1
Peroneal Nerve Palsy	1	1
Tissue Damage	1	1
Aneurysm	1	1
Hemorrhage/Bleeding	1	1
Unintended Radiation Exposure	1	1

Recalls
Manufacturer		Recall Class	Date Posted
1	The Anspach Effort, Inc.	II	Jan-07-2023