TPLC - Total Product Life Cycle

• Device: operating room accessories table tray
• Definition: This product code has been established in accordance with the may 20, 1997, guidance entitled, convenience kits interim regulatory guidance, found at www.Fda.Gov/cdrh/ode/convkit.Html. This type of convenience kit, as listed in the guidance above, is under enforcement discretion, and does not require a premarket notification (510(k)) to market if it meets all criteria in the guidance.
• Product Code: FWZ
• Regulation Number: 878.4950
• Device Class: 1

MDR Year	MDR Reports	MDR Events
2018	120	120
2019	99	99
2020	464	464
2021	337	337
2022	56	56
2023	8	8

Device Problems	MDRs with this Device Problem	Events in those MDRs
Mechanical Problem	330	330
Unintended Movement	114	114
Device Slipped	79	79
Unstable	79	79
Loose or Intermittent Connection	78	78
Break	73	73
Positioning Problem	46	46
Deformation Due to Compressive Stress	39	39
Physical Resistance/Sticking	31	31
Mechanics Altered	30	30
Positioning Failure	29	29
Device Handling Problem	28	28
Leak/Splash	21	21
Fitting Problem	18	18
Naturally Worn	16	16
Adverse Event Without Identified Device or Use Problem	15	15
Mechanical Jam	15	15
Decrease in Pressure	13	13
Material Integrity Problem	12	12
Insufficient Information	10	10
Connection Problem	10	10
Detachment of Device or Device Component	9	9
Component Missing	9	9
Fluid/Blood Leak	9	9
Device Dislodged or Dislocated	7	7
Material Deformation	6	6
Material Twisted/Bent	5	5
Noise, Audible	5	5
Difficult to Open or Close	5	5
Failure to Cut	4	4
Defective Device	4	4
Material Split, Cut or Torn	4	4
Appropriate Term/Code Not Available	3	3
Device Operates Differently Than Expected	3	3
Fracture	3	3
Low Readings	3	3
Use of Device Problem	3	3
Off-Label Use	3	3
Device Inoperable	3	3
Failure to Clean Adequately	3	3
Device Fell	2	2
Material Too Rigid or Stiff	2	2
Product Quality Problem	2	2
Material Fragmentation	2	2
Collapse	2	2
Detachment Of Device Component	2	2
Problem with Removal of Enzymatic Cleaner	2	2
Unintended System Motion	2	2
Material Separation	2	2
Contamination /Decontamination Problem	2	2
Pressure Problem	2	2
Failure to Eject	2	2
Packaging Problem	1	1
Device Markings/Labelling Problem	1	1
Device Tipped Over	1	1
Patient-Device Incompatibility	1	1
Battery Problem	1	1
Device-Device Incompatibility	1	1
Device Contamination with Chemical or Other Material	1	1
Compatibility Problem	1	1
Device Contaminated During Manufacture or Shipping	1	1
Manufacturing, Packaging or Shipping Problem	1	1
Migration or Expulsion of Device	1	1
Bent	1	1
Crack	1	1
Material Frayed	1	1
Inflation Problem	1	1
Labelling, Instructions for Use or Training Problem	1	1
Incorrect, Inadequate or Imprecise Result or Readings	1	1
Material Puncture/Hole	1	1
Material Rupture	1	1
Vibration	1	1
Device Damaged Prior to Use	1	1
Defective Component	1	1
Split	1	1
Incomplete or Missing Packaging	1	1
Sharp Edges	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	366	366
No Known Impact Or Consequence To Patient	335	335
No Consequences Or Impact To Patient	197	197
No Patient Involvement	118	118
Laceration(s)	18	18
No Information	14	14
Injury	10	10
Insufficient Information	8	8
Fall	5	5
Bone Fracture(s)	4	4
Pain	3	3
No Code Available	3	3
Needle Stick/Puncture	2	2
Bruise/Contusion	2	2
Cellulitis	1	1
Erythema	1	1
Abrasion	1	1
Airway Obstruction	1	1
Bacterial Infection	1	1
Hematoma	1	1
Hemorrhage/Bleeding	1	1
High Blood Pressure/ Hypertension	1	1
Unspecified Infection	1	1
Inflammation	1	1
Paresis	1	1
Swelling	1	1
Tissue Damage	1	1
Necrosis	1	1
Hernia	1	1
Skin Tears	1	1
Ambulation Difficulties	1	1
Blood Loss	1	1
Limb Fracture	1	1
Blister	1	1
Swelling/ Edema	1	1
Fasciitis	1	1