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	302	302
Unstable	102	102
Unintended Movement	98	98
Device Slipped	94	94
Loose or Intermittent Connection	53	53
Positioning Problem	43	43
Deformation Due to Compressive Stress	39	39
Physical Resistance/Sticking	37	37
Mechanics Altered	33	33
Break	32	32
Device Handling Problem	29	29
Positioning Failure	19	19
Adverse Event Without Identified Device or Use Problem	18	18
Fitting Problem	17	17
Leak/Splash	16	16
Mechanical Jam	14	14
Decrease in Pressure	13	13
Naturally Worn	12	12
Material Integrity Problem	12	12
Connection Problem	9	9
Fluid/Blood Leak	8	8
Detachment of Device or Device Component	7	7
Difficult to Open or Close	6	6
Defective Device	6	6
Material Twisted/Bent	6	6
Component Missing	6	6
Material Deformation	5	5
Insufficient Information	5	5
Device Dislodged or Dislocated	4	4
Noise, Audible	3	3
Fracture	3	3
Low Readings	3	3
Delivered as Unsterile Product	3	3
Failure to Cut	3	3
Use of Device Problem	3	3
Device Fell	3	3
Material Fragmentation	2	2
Degraded	2	2
Contamination /Decontamination Problem	2	2
Failure to Clean Adequately	2	2
Packaging Problem	2	2
Material Separation	2	2
Problem with Removal of Enzymatic Cleaner	2	2
Failure to Eject	2	2
Material Split, Cut or Torn	2	2
Device-Device Incompatibility	2	2
Battery Problem	1	1
Incorrect, Inadequate or Imprecise Result or Readings	1	1
Material Too Rigid or Stiff	1	1
Manufacturing, Packaging or Shipping Problem	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	445	445
No Known Impact Or Consequence To Patient	256	256
No Patient Involvement	106	106
No Consequences Or Impact To Patient	88	88
Laceration(s)	31	31
Insufficient Information	25	25
No Information	13	13
Injury	7	7
Abrasion	5	5
Neck Stiffness	4	4
Pain	4	4
Fall	4	4
Ambulation Difficulties	3	3
Bruise/Contusion	3	3
Hemorrhage/Bleeding	2	2
Bacterial Infection	2	2
Swelling/ Edema	2	2
Concussion	2	2
Needle Stick/Puncture	2	2
Neck Pain	2	2
Paresthesia	2	2
Blister	2	2
Multiple Fractures	2	2
Head Injury	2	2
Bone Fracture(s)	2	2
Erythema	1	1
Nerve Damage	1	1
Septic Shock	1	1
Swelling	1	1
Urinary Retention	1	1
Cellulitis	1	1
Paresis	1	1
Eye Injury	1	1
Limb Fracture	1	1
Fasciitis	1	1
Unspecified Tissue Injury	1	1
Muscle Weakness	1	1
Skin Tears	1	1
Convulsion/Seizure	1	1
Unspecified Respiratory Problem	1	1
Airway Obstruction	1	1
Unspecified Musculoskeletal problem	1	1
Necrosis	1	1

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