TPLC - Total Product Life Cycle

• Device: motor, surgical instrument, ac-powered
• Product Code: GEY
• Regulation Number: 878.4820
• Device Class: 1

MDR Year	MDR Reports	MDR Events
2018	1288	1288
2019	1131	1131
2020	952	952
2021	1146	1146
2022	1361	1361
2023	467	467

Device Problems	MDRs with this Device Problem	Events in those MDRs
Physical Resistance/Sticking	1550	1550
Mechanical Jam	986	986
Complete Loss of Power	916	916
Unintended System Motion	694	694
Excessive Heating	653	653
Noise, Audible	423	423
Detachment of Device or Device Component	399	399
Fail-Safe Problem	256	256
Material Fragmentation	235	235
Intermittent Loss of Power	220	220
Device Alarm System	174	174
Output below Specifications	168	168
Appropriate Term/Code Not Available	161	161
Vibration	151	151
Intermittent Energy Output	142	142
Overheating of Device	138	138
Device-Device Incompatibility	137	137
Leak/Splash	134	134
Fluid/Blood Leak	129	129
Break	125	125
Unexpected Shutdown	111	111
Material Frayed	65	65
Fail-Safe Did Not Operate	63	63
Positioning Problem	62	62
Device Operates Differently Than Expected	57	57
Device Stops Intermittently	51	51
Fracture	49	49
Device Slipped	48	48
Mechanical Problem	41	41
Loose or Intermittent Connection	30	30
Device Inoperable	30	30
Premature Separation	28	28
Difficult or Delayed Separation	23	23
Adverse Event Without Identified Device or Use Problem	23	23
Connection Problem	23	23
Material Twisted/Bent	21	21
Device Reprocessing Problem	20	20
Detachment Of Device Component	19	19
Packaging Problem	17	17
Material Deformation	10	10
Circuit Failure	10	10
Difficult to Remove	10	10
Electrical /Electronic Property Problem	9	9
Environmental Particulates	9	9
Contamination /Decontamination Problem	8	8
Component Missing	8	8
Separation Failure	8	8
Incomplete or Inadequate Connection	8	8
Crack	7	7
Energy Output Problem	6	6
Device Contaminated During Manufacture or Shipping	6	6
Device Operational Issue	5	5
Difficult to Open or Close	4	4
Defective Component	4	4
Material Separation	4	4
Peeled/Delaminated	4	4
Difficult To Position	4	4
Corroded	4	4
Separation Problem	4	4
Failure to Clean Adequately	4	4
Power Problem	3	3
Unintended Movement	3	3
Premature Discharge of Battery	3	3
Difficult to Insert	3	3
Device Damaged by Another Device	3	3
Failure to Disconnect	3	3
Dent in Material	2	2
Device Markings/Labelling Problem	2	2
Electrical Shorting	2	2
Device Contamination with Chemical or Other Material	2	2
Use of Device Problem	2	2
Smoking	2	2
Suction Problem	2	2
Dull, Blunt	2	2
Positioning Failure	2	2
Loss of Power	2	2
Suction Failure	2	2
Naturally Worn	2	2
No Fail-Safe Mechanism	1	1
Operating System Becomes Nonfunctional	1	1
Pumping Problem	1	1
Reset Problem	1	1
Scratched Material	1	1
Temperature Problem	1	1
Mechanics Altered	1	1
Material Integrity Problem	1	1
Failure of Device to Self-Test	1	1
Unintended Electrical Shock	1	1
Misassembly by Users	1	1
No Apparent Adverse Event	1	1
Device Handling Problem	1	1
Explosion	1	1
Material Rupture	1	1
No Device Output	1	1
Particulates	1	1
Insufficient Heating	1	1
Melted	1	1
Intermittent Continuity	1	1
Complete Blockage	1	1
Air Leak	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	3089	3089
No Consequences Or Impact To Patient	2501	2501
No Known Impact Or Consequence To Patient	702	702
No Patient Involvement	15	15
Not Applicable	10	10
Bone Fracture(s)	9	9
Foreign Body In Patient	6	6
Injury	5	5
Burn(s)	4	4
No Code Available	4	4
Embolism/Embolus	4	4
Limb Fracture	4	4
Insufficient Information	3	3
Unspecified Tissue Injury	2	2
Abrasion	2	2
Unspecified Infection	2	2
Laceration(s)	2	2
Post Operative Wound Infection	2	2
Tissue Damage	2	2
Tingling	1	1
Superficial (First Degree) Burn	1	1
Electric Shock	1	1
Blood Loss	1	1
Nerve Damage	1	1
Skin Irritation	1	1
Hemorrhage/Bleeding	1	1
No Information	1	1
Partial thickness (Second Degree) Burn	1	1
Device Embedded In Tissue or Plaque	1	1

Recalls
Manufacturer		Recall Class	Date Posted
1	Pro-Dex Inc	II	Aug-22-2019