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	155	155

Device Problems	MDRs with this Device Problem	Events in those MDRs
Detachment of Device or Device Component	1148	1148
Peeled/Delaminated	737	737
Corroded	277	277
Crack	190	190
Degraded	113	113
Flaked	108	108
Break	95	95
Material Integrity Problem	85	85
Mechanical Problem	82	82
Device Fell	51	51
Fluid/Blood Leak	43	43
Material Erosion	42	42
Leak/Splash	40	40
Material Fragmentation	40	40
Fracture	27	27
No Apparent Adverse Event	27	27
Use of Device Problem	18	18
Material Separation	18	18
Grounding Malfunction	17	17
Material Split, Cut or Torn	17	17
Unintended Movement	15	15
Insufficient Information	14	14
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
Loose or Intermittent Connection	5	5
Radiation Output Problem	5	5
Overheating of Device	5	5
Output Problem	5	5
Failure to Clean Adequately	5	5
Unexpected Shutdown	5	5
Adverse Event Without Identified Device or Use Problem	5	5
Contamination /Decontamination Problem	5	5
Pitted	5	5
Improper or Incorrect Procedure or Method	5	5
Radiation Overexposure	5	5
Defective Component	4	4
Smoking	4	4
Installation-Related Problem	4	4
Misassembly During Maintenance/Repair	4	4
Naturally Worn	3	3
Unintended Collision	3	3
Particulates	3	3
Appropriate Term/Code Not Available	2	2
Structural Problem	2	2
Component Misassembled	2	2
Power Problem	2	2
Contamination	2	2
Tear, Rip or Hole in Device Packaging	2	2
Patient Device Interaction Problem	2	2
Off-Label Use	2	2
Loss of Power	2	2
Device Handling Problem	2	2
Defective Device	2	2
Separation Problem	2	2
Scratched Material	2	2
Complete Loss of Power	1	1
Device Damaged Prior to Use	1	1
Device Slipped	1	1
Ejection Problem	1	1
Misassembly by Users	1	1
Environmental Compatibility Problem	1	1
Protective Measures Problem	1	1
Separation Failure	1	1
Device Contamination with Chemical or Other Material	1	1
Accessory Incompatible	1	1
Material Deformation	1	1
Decoupling	1	1
Compatibility Problem	1	1
Battery Problem	1	1
Burst Container or Vessel	1	1
Material Twisted/Bent	1	1
Misassembled During Installation	1	1
Sparking	1	1
Fire	1	1
Misassembled	1	1
Circuit Failure	1	1
Activation Failure	1	1
Output above Specifications	1	1
Device Tipped Over	1	1
Inadequate Lubrication	1	1
Melted	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	1501	1501
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
Superficial (First Degree) Burn	3	3
Foreign Body In Patient	3	3
Headache	3	3
Head Injury	2	2
Patient Problem/Medical Problem	2	2
Eye Injury	2	2
Burning Sensation	1	1
No Code Available	1	1
Bone Fracture(s)	1	1
Swelling	1	1
Hematoma	1	1
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	1	1
Skin Tears	1	1
Pain	1	1
Device Embedded In Tissue or Plaque	1	1
Burn, Thermal	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