TPLC - Total Product Life Cycle

• Device: light, surgical, ceiling mounted
• Product Code: FSY
• Regulation Number: 878.4580
• Device Class: 2

MDR Year	MDR Reports	MDR Events
2019	444	444
2020	439	439
2021	380	380
2022	430	430
2023	661	661
2024	275	275

Device Problems	MDRs with this Device Problem	Events in those MDRs
Detachment of Device or Device Component	1212	1212
Peeled/Delaminated	791	791
Corroded	283	283
Crack	197	197
Degraded	114	114
Flaked	108	108
Break	97	97
Material Integrity Problem	85	85
Mechanical Problem	82	82
Device Fell	52	52
Fluid/Blood Leak	44	44
Material Erosion	42	42
Leak/Splash	41	41
Material Fragmentation	40	40
No Apparent Adverse Event	31	31
Fracture	29	29
Material Separation	20	20
Use of Device Problem	18	18
Material Split, Cut or Torn	18	18
Grounding Malfunction	17	17
Insufficient Information	15	15
Unintended Movement	15	15
Temperature Problem	13	13
Electrical /Electronic Property Problem	11	11
Material Disintegration	9	9
Moisture Damage	8	8
Component Missing	8	8
Device Dislodged or Dislocated	6	6
Radiation Overexposure	5	5
Contamination /Decontamination Problem	5	5
Adverse Event Without Identified Device or Use Problem	5	5
Output Problem	5	5
Overheating of Device	5	5
Loose or Intermittent Connection	5	5
Improper or Incorrect Procedure or Method	5	5
Pitted	5	5
Failure to Clean Adequately	5	5
Unexpected Shutdown	5	5
Radiation Output Problem	5	5
Misassembly During Maintenance/Repair	4	4
Smoking	4	4
Defective Component	4	4
Installation-Related Problem	4	4
Naturally Worn	3	3
Particulates	3	3
Unintended Collision	3	3
Loss of Power	2	2
Off-Label Use	2	2
Contamination	2	2
Difficult or Delayed Positioning	2	2
Power Problem	2	2
Scratched Material	2	2
Appropriate Term/Code Not Available	2	2
Device Handling Problem	2	2
Tear, Rip or Hole in Device Packaging	2	2
Structural Problem	2	2
Defective Device	2	2
Separation Problem	2	2
Patient Device Interaction Problem	2	2
Component Misassembled	2	2
Ejection Problem	1	1
Excessive Heating	1	1
Complete Loss of Power	1	1
Misassembled During Installation	1	1
Inadequate Lubrication	1	1
Device Tipped Over	1	1
Sparking	1	1
Battery Problem	1	1
Separation Failure	1	1
Material Deformation	1	1
Environmental Compatibility Problem	1	1
Environmental Particulates	1	1
Device Contamination with Chemical or Other Material	1	1
Compatibility Problem	1	1
Activation Failure	1	1
Misassembly by Users	1	1
Protective Measures Problem	1	1
Material Twisted/Bent	1	1
Decoupling	1	1
Accessory Incompatible	1	1
Burst Container or Vessel	1	1
Circuit Failure	1	1
Fire	1	1
Device Damaged Prior to Use	1	1
Device Slipped	1	1
Output above Specifications	1	1
Melted	1	1
Misassembled	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	1617	1617
No Consequences Or Impact To Patient	519	519
No Known Impact Or Consequence To Patient	306	306
No Patient Involvement	125	125
Burn(s)	21	21
Insufficient Information	16	16
Injury	8	8
Full thickness (Third Degree) Burn	7	7
Skin Discoloration	5	5
Concussion	5	5
Bruise/Contusion	5	5
Laceration(s)	4	4
Headache	3	3
Skin Tears	3	3
Superficial (First Degree) Burn	3	3
Foreign Body In Patient	3	3
Patient Problem/Medical Problem	2	2
Head Injury	2	2
Eye Injury	2	2
Bone Fracture(s)	1	1
Hematoma	1	1
Pain	1	1
Burn, Thermal	1	1
Swelling	1	1
Burning Sensation	1	1
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	1	1
Device Embedded In Tissue or Plaque	1	1
No Code Available	1	1
Unspecified Tissue Injury	1	1

Recalls
Manufacturer		Recall Class	Date Posted
1	DKK Dai-Ichi Shomei Co., Ltd.	II	Oct-06-2023
2	GETINGE US SALES LLC	II	Mar-07-2019
3	Getinge Usa Sales Inc	II	Jan-19-2024
4	Getinge Usa Sales Inc	II	Jun-30-2022
5	Stryker Communications	II	Apr-09-2024
6	Stryker Communications	II	Mar-27-2020
7	Stryker Communications	II	Sep-12-2019
8	Stryker Communications	II	Aug-30-2019
9	Stryker Communications	II	May-21-2019