TPLC - Total Product Life Cycle

show TPLC since

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 Inoperable	5	5
Noise, Audible	5	5
Device-Device Incompatibility	5	5
Fracture	4	4
Detachment Of Device Component	3	3
Excessive Heating	3	3
Material Deformation	2	2
Partial Blockage	2	2
Mechanical Jam	2	2
Vibration	2	2
Use of Device Problem	2	2
Output below Specifications	2	2
Adverse Event Without Identified Device or Use Problem	2	2
Contamination /Decontamination Problem	1	1
Intermittent Continuity	1	1
Device Displays Incorrect Message	1	1
Connection Problem	1	1
Component Missing	1	1
Disassembly	1	1
No Apparent Adverse Event	1	1
Maintenance Does Not Comply To Manufacturers Recommendations	1	1
Material Integrity Problem	1	1
Power Problem	1	1
Defective Component	1	1
Hole In Material	1	1
Expulsion	1	1
Unintended Movement	1	1
Fitting Problem	1	1
Physical Resistance/Sticking	1	1
Sticking	1	1
Fluid/Blood Leak	1	1
Temperature Problem	1	1
Mechanical Problem	1	1
Crack	1	1
Naturally Worn	1	1
Improper Flow or Infusion	1	1
Failure to Align	1	1
Insufficient Information	1	1
Dull, Blunt	1	1
Component Falling	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
No Patient Involvement	18	18
Foreign Body In Patient	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
Foreign Body Reaction	1	1
Hearing Impairment	1	1
Unspecified Infection	1	1
Laceration(s)	1	1
Pain	1	1
Tinnitus	1	1
Superficial (First Degree) Burn	1	1