TPLC - Total Product Life Cycle

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Device	operating room accessories table tray
Regulation Description	Manual operating table and accessories and manual operating chair and accessories.
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

Device Problems	MDRs with this Device Problem	Events in those MDRs
Mechanical Problem	160	160
Device Slipped	79	79
Unstable	77	77
Unintended Movement	61	61
Mechanics Altered	35	35
Loose or Intermittent Connection	20	20
Break	20	20
Physical Resistance/Sticking	20	20
Adverse Event Without Identified Device or Use Problem	12	12
Decrease in Pressure	11	11
Leak/Splash	10	10
Naturally Worn	9	9
Mechanical Jam	8	8
Detachment of Device or Device Component	7	7
Material Twisted/Bent	7	8
Difficult to Open or Close	5	5
Contamination /Decontamination Problem	5	5
Positioning Problem	4	4
Device Fell	3	3
Failure to Cut	3	3
Delivered as Unsterile Product	3	3
Defective Device	2	2
Degraded	2	2
Positioning Failure	2	2
Material Deformation	2	2
Packaging Problem	2	2
Fracture	2	2
Connection Problem	2	2
Device-Device Incompatibility	2	2
Fitting Problem	2	2
Fluid/Blood Leak	2	2
Material Fragmentation	1	1
Vibration	1	1
Material Erosion	1	1
Crack	1	1
Device Handling Problem	1	1
Incomplete or Missing Packaging	1	1
Explosion	1	1
Device Dislodged or Dislocated	1	1
Appropriate Term/Code Not Available	1	1
Nonstandard Device	1	1
Pressure Problem	1	1
Overheating of Device	1	1
Device Contaminated During Manufacture or Shipping	1	1
Noise, Audible	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	426	427
No Known Impact Or Consequence To Patient	37	37
Insufficient Information	25	25
Laceration(s)	24	24
No Patient Involvement	6	6
Abrasion	4	4
Neck Stiffness	4	4
Pain	3	3
Ambulation Difficulties	3	3
Bone Fracture(s)	2	2
Head Injury	2	2
Multiple Fractures	2	2
Blister	2	2
Paresthesia	2	2
Neck Pain	2	2
Concussion	2	2
Fall	2	2
Swelling/ Edema	2	2
Bacterial Infection	2	2
Hemorrhage/Bleeding	2	2
Bruise/Contusion	2	2
Necrosis	1	1
Unspecified Musculoskeletal problem	1	1
Muscle Weakness	1	1
Cellulitis	1	1
Septic Shock	1	1
Nerve Damage	1	1
Urinary Retention	1	1
Paresis	1	1
Eye Injury	1	1
Fasciitis	1	1
Unspecified Tissue Injury	1	1
Skin Tears	1	1
Convulsion/Seizure	1	1
Unspecified Respiratory Problem	1	1
No Consequences Or Impact To Patient	1	1
Airway Obstruction	1	1

Recalls
Manufacturer		Recall Class	Date Posted
1	Baxter Healthcare Corporation	II	Mar-12-2024