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	161	161
Device Slipped	85	85
Unstable	82	82
Unintended Movement	62	62
Mechanics Altered	35	35
Break	21	21
Loose or Intermittent Connection	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	8	8
Material Twisted/Bent	7	8
Difficult to Open or Close	5	5
Positioning Problem	5	5
Contamination /Decontamination Problem	5	5
Device Fell	4	4
Delivered as Unsterile Product	4	4
Fracture	3	3
Failure to Cut	3	3
Fluid/Blood Leak	2	2
Connection Problem	2	2
Packaging Problem	2	2
Material Deformation	2	2
Positioning Failure	2	2
Degraded	2	2
Defective Device	2	2
Material Split, Cut or Torn	2	2
Device-Device Incompatibility	2	2
Fitting Problem	2	2
Material Fragmentation	1	1
Material Integrity Problem	1	1
Manufacturing, Packaging or Shipping Problem	1	1
Vibration	1	1
Material Erosion	1	1
Device Handling Problem	1	1
Crack	1	1
Explosion	1	1
Incomplete or Missing Packaging	1	1
Device Dislodged or Dislocated	1	1
Appropriate Term/Code Not Available	1	1
Nonstandard Device	1	1
Separation Problem	1	1
Overheating of Device	1	1
Pressure Problem	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	440	441
No Known Impact Or Consequence To Patient	37	37
Laceration(s)	28	28
Insufficient Information	26	26
Abrasion	6	6
No Patient Involvement	6	6
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
Nerve Damage	1	1
Septic Shock	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