TPLC - Total Product Life Cycle

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Device	instrument, surgical, orthopedic, pneumatic powered & accessory/attachment
Product Code	HSZ
Regulation Number	878.4820
Device Class	1

Device Problems	MDRs with this Device Problem	Events in those MDRs
Break	86	86
Failure to Cut	25	25
Air Leak	22	22
Material Rupture	21	21
Entrapment of Device	17	17
Leak/Splash	13	13
Device Operates Differently Than Expected	9	9
Overheating of Device	8	8
Burst Container or Vessel	7	7
Device-Device Incompatibility	5	5
Noise, Audible	5	5
Device Inoperable	5	5
Fracture	4	4
Detachment Of Device Component	3	3
Excessive Heating	3	3
Adverse Event Without Identified Device or Use Problem	2	2
Material Deformation	2	2
Output below Specifications	2	2
Use of Device Problem	2	2
Mechanical Jam	2	2
Vibration	2	2
Partial Blockage	2	2
Dull, Blunt	1	1
Component Falling	1	1
Fluid/Blood Leak	1	1
Temperature Problem	1	1
Hole In Material	1	1
Device Displays Incorrect Message	1	1
Naturally Worn	1	1
Connection Problem	1	1
Intermittent Continuity	1	1
No Apparent Adverse Event	1	1
Sticking	1	1
Material Integrity Problem	1	1
Disassembly	1	1
Defective Component	1	1
Unintended Movement	1	1
Insufficient Information	1	1
Crack	1	1
Maintenance Does Not Comply To Manufacturers Recommendations	1	1
Power Problem	1	1
Failure to Align	1	1
Component Missing	1	1
Improper Flow or Infusion	1	1
Contamination /Decontamination Problem	1	1
Physical Resistance/Sticking	1	1
Mechanical Problem	1	1
Fitting Problem	1	1
Expulsion	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	87	87
No Known Impact Or Consequence To Patient	54	54
No Consequences Or Impact To Patient	28	28
Foreign Body In Patient	18	18
No Patient Involvement	18	18
No Code Available	6	6
Insufficient Information	6	6
No Information	5	5
Device Embedded In Tissue or Plaque	3	3
Burn(s)	2	2
Hearing Impairment	1	1
Unspecified Infection	1	1
Superficial (First Degree) Burn	1	1
Foreign Body Reaction	1	1
Laceration(s)	1	1
Pain	1	1
Tinnitus	1	1