TPLC - Total Product Life Cycle

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Device	instrument, surgical, orthopedic, ac-powered motor and accessory/attachment
Product Code	HWE
Regulation Number	878.4820
Device Class	1

Device Problems	MDRs with this Device Problem	Events in those MDRs
Physical Resistance/Sticking	3651	3731
Mechanical Jam	2844	2844
Complete Loss of Power	2772	2772
Output below Specifications	1624	1624
Fracture	1597	2226
Break	1426	1456
Excessive Heating	1418	1418
Noise, Audible	1025	1025
Detachment of Device or Device Component	1000	1801
Appropriate Term/Code Not Available	789	789
Unintended System Motion	776	777
Failure to Cut	576	576
Intermittent Loss of Power	533	533
Overheating of Device	504	692
Device-Device Incompatibility	430	430
Fluid/Blood Leak	319	885
Device Remains Activated	241	854
Material Fragmentation	176	265
Unexpected Shutdown	175	175
Material Disintegration	166	443
Naturally Worn	164	164
Vibration	162	162
Material Twisted/Bent	160	160
Leak/Splash	157	157
Mechanical Problem	144	146
Device Slipped	141	141
Intermittent Energy Output	134	134
Premature Separation	118	118
Fail-Safe Did Not Operate	110	243
Entrapment of Device	109	109
Fail-Safe Problem	104	243
Flaked	102	1090
Material Deformation	84	85
Corroded	81	81
Crack	69	69
Adverse Event Without Identified Device or Use Problem	68	68
Defective Device	68	68
Difficult to Open or Close	60	255
Material Separation	56	56
Unintended Movement	47	47
Electrical /Electronic Property Problem	44	44
Material Integrity Problem	42	42
Energy Output Problem	42	42
Unintended Power Up	41	49
Dull, Blunt	38	38
Compatibility Problem	37	37
Smoking	30	30
Environmental Particulates	28	28
Material Split, Cut or Torn	27	27
Contamination /Decontamination Problem	24	24

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	12361	16048
No Consequences Or Impact To Patient	4562	5319
No Known Impact Or Consequence To Patient	905	1301
No Patient Involvement	511	1561
Insufficient Information	444	583
Foreign Body In Patient	371	371
Device Embedded In Tissue or Plaque	112	112
Not Applicable	99	99
No Code Available	91	91
Burn(s)	50	50
No Information	42	106
Injury	31	31
Skin Tears	26	26
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	19	19
Unspecified Tissue Injury	16	16
Bone Fracture(s)	15	15
Superficial (First Degree) Burn	10	10
Pain	9	9
Unspecified Infection	8	8
Failure of Implant	7	7
Tissue Damage	6	6
Laceration(s)	6	6
Abrasion	4	4
Burn, Thermal	4	4
Cardiac Perforation	4	4
Infiltration into Tissue	3	3
Brain Injury	3	3
Patient Problem/Medical Problem	3	3
Perforation	2	2
Skin Irritation	2	2
Hemorrhage/Bleeding	2	2
Full thickness (Third Degree) Burn	2	2
Alteration In Body Temperature	1	1
Skin Discoloration	1	2
Rupture	1	1
Nerve Damage	1	1
Sprain	1	1
Limb Fracture	1	1
Shock	1	1
Non-union Bone Fracture	1	1
Swelling/ Edema	1	1
Hypersensitivity/Allergic reaction	1	1
Arrhythmia	1	1
Damage to Ligament(s)	1	1
Hearing Impairment	1	1
Tinnitus	1	1

Recalls
Manufacturer		Recall Class	Date Posted
1	Encore Medical, Lp	II	Jul-27-2019