TPLC - Total Product Life Cycle

• Device: light source, fiberoptic, routine
• Product Code: FCW
• Regulation Number: 876.1500
• Device Class: 2

MDR Year	MDR Reports	MDR Events
2017	59	59
2018	76	76
2019	118	118
2020	152	152
2021	147	147
2022	166	166
2023	179	179
2024	41	41

Device Problems	MDRs with this Device Problem	Events in those MDRs
Output Problem	163	163
Overheating of Device	141	141
Smoking	83	83
Temperature Problem	80	80
Circuit Failure	67	67
Device Emits Odor	65	65
Electrical /Electronic Property Problem	51	51
Display or Visual Feedback Problem	49	49
No Display/Image	40	40
Thermal Decomposition of Device	37	37
Melted	36	36
Adverse Event Without Identified Device or Use Problem	35	35
Failure to Power Up	31	31
Break	30	30
Power Problem	28	28
Poor Quality Image	27	27
Loss of Power	21	21
Fire	19	19
Intermittent Continuity	18	18
Sparking	16	16
Detachment of Device or Device Component	16	16
Optical Problem	15	15
Intermittent Loss of Power	15	15
Use of Device Problem	11	11
Mechanical Problem	11	11
Unexpected Shutdown	9	9
Excessive Heating	8	8
Noise, Audible	7	7
Loose or Intermittent Connection	7	7
Connection Problem	7	7
Device Operates Differently Than Expected	6	6
Electrical Shorting	6	6
No Device Output	6	6
Computer Software Problem	6	6
Crack	5	5
Environmental Particulates	5	5
Failure to Shut Off	5	5
Flare or Flash	5	5
Environmental Compatibility Problem	4	4
Electrical Power Problem	4	4
Energy Output Problem	4	4
Insufficient Information	4	4
Device Contaminated During Manufacture or Shipping	4	4
Device Fell	4	4
Appropriate Term/Code Not Available	3	3
Erratic or Intermittent Display	3	3
Disconnection	3	3
Application Program Problem	3	3
Blocked Connection	3	3
Defective Device	3	3
Device Displays Incorrect Message	2	2
Improper or Incorrect Procedure or Method	2	2
Activation, Positioning or Separation Problem	2	2
Human-Device Interface Problem	2	2
Unintended Power Up	2	2
Material Discolored	2	2
Component Falling	2	2
Output above Specifications	2	2
Device Handling Problem	2	2
Therapeutic or Diagnostic Output Failure	2	2
Unintended Movement	2	2
Light Interference	2	2
Material Integrity Problem	2	2
Complete Loss of Power	2	2
Intermittent Energy Output	2	2
Separation Problem	2	2
Premature Separation	1	1
Illegible Information	1	1
Intermittent Communication Failure	1	1
Mechanical Jam	1	1
Mechanics Altered	1	1
Optical Obstruction	1	1
Reset Problem	1	1
Patient Device Interaction Problem	1	1
Explosion	1	1
Material Split, Cut or Torn	1	1
Physical Resistance/Sticking	1	1
Peeled/Delaminated	1	1
Power Conditioning Problem	1	1
Material Frayed	1	1
Hole In Material	1	1
Image Display Error/Artifact	1	1
Component Incompatible	1	1
Detachment Of Device Component	1	1
Device Alarm System	1	1
No Audible Alarm	1	1
Positioning Failure	1	1
Material Disintegration	1	1
Inadequate Lighting	1	1
Device Contamination with Chemical or Other Material	1	1
Device-Device Incompatibility	1	1
Component or Accessory Incompatibility	1	1
Loss of Data	1	1
Electro-Static Discharge	1	1
Fitting Problem	1	1
Defective Component	1	1
Failure to Align	1	1
Fumes or Vapors	1	1
Arcing	1	1
Ambient Noise Problem	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	497	497
No Known Impact Or Consequence To Patient	198	198
No Consequences Or Impact To Patient	128	128
Insufficient Information	67	67
Burn(s)	50	50
No Patient Involvement	26	26
Superficial (First Degree) Burn	14	14
Burn, Thermal	13	13
Not Applicable	11	11
No Information	3	3
No Code Available	2	2
Patient Problem/Medical Problem	2	2
Partial thickness (Second Degree) Burn	2	2
Full thickness (Third Degree) Burn	2	2
Injury	2	2
Shock	1	1
Electric Shock	1	1
Foreign Body In Patient	1	1
Unspecified Tissue Injury	1	1

Recalls
Manufacturer		Recall Class	Date Posted
1	Stryker Corporation	II	Apr-28-2023