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	214	214

Device Problems	MDRs with this Device Problem	Events in those MDRs
Detachment of Device or Device Component	1182	1182
Peeled/Delaminated	763	763
Corroded	282	282
Crack	194	194
Degraded	113	113
Flaked	108	108
Break	96	96
Material Integrity Problem	85	85
Mechanical Problem	82	82
Device Fell	51	51
Fluid/Blood Leak	44	44
Material Erosion	42	42
Leak/Splash	41	41
Material Fragmentation	40	40
Fracture	28	28
No Apparent Adverse Event	28	28
Material Separation	18	18
Use of Device Problem	18	18
Grounding Malfunction	17	17
Material Split, Cut or Torn	17	17
Insufficient Information	15	15
Unintended Movement	15	15
Temperature Problem	13	13
Electrical /Electronic Property Problem	11	11
Material Disintegration	9	9
Component Missing	8	8
Device Dislodged or Dislocated	6	6
Moisture Damage	6	6
Pitted	5	5
Improper or Incorrect Procedure or Method	5	5
Overheating of Device	5	5
Loose or Intermittent Connection	5	5
Contamination /Decontamination Problem	5	5
Radiation Overexposure	5	5
Adverse Event Without Identified Device or Use Problem	5	5
Output Problem	5	5
Unexpected Shutdown	5	5
Radiation Output Problem	5	5
Failure to Clean Adequately	5	5
Misassembly During Maintenance/Repair	4	4
Defective Component	4	4
Installation-Related Problem	4	4
Smoking	4	4
Particulates	3	3
Unintended Collision	3	3
Naturally Worn	3	3
Appropriate Term/Code Not Available	2	2
Device Handling Problem	2	2
Power Problem	2	2
Scratched Material	2	2
Tear, Rip or Hole in Device Packaging	2	2
Structural Problem	2	2
Defective Device	2	2
Loss of Power	2	2
Off-Label Use	2	2
Contamination	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
Inadequate Lubrication	1	1
Misassembled During Installation	1	1
Accessory Incompatible	1	1
Burst Container or Vessel	1	1
Circuit Failure	1	1
Decoupling	1	1
Fire	1	1
Output above Specifications	1	1
Melted	1	1
Misassembled	1	1
Device Slipped	1	1
Device Damaged Prior to Use	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
Device Contamination with Chemical or Other Material	1	1
Compatibility Problem	1	1
Material Twisted/Bent	1	1
Protective Measures Problem	1	1
Activation Failure	1	1
Misassembly by Users	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	1560	1560
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	15	15
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
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
Skin Tears	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

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