TPLC - Total Product Life Cycle

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Device	laparoscopy kit
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	FDE
Regulation Number	876.1500
Device Class	2

Device Problems	MDRs with this Device Problem	Events in those MDRs
Material Integrity Problem	20	20
Break	19	19
Component Missing	8	8
Appropriate Term/Code Not Available	8	8
Packaging Problem	7	7
Device Contamination with Chemical or Other Material	7	7
Contamination	7	7
Material Fragmentation	6	6
Contamination /Decontamination Problem	6	6
Material Puncture/Hole	5	5
Detachment of Device or Device Component	4	4
Device Fell	4	4
Adverse Event Without Identified Device or Use Problem	3	3
Defective Device	3	3
Material Separation	3	3
Unraveled Material	3	3
Flaked	3	3
Material Frayed	3	3
Detachment Of Device Component	3	3
Use of Device Problem	2	2
Fire	2	2
Connection Problem	2	2
Device Markings/Labelling Problem	2	2
Material Split, Cut or Torn	2	2
Device Dislodged or Dislocated	2	2
Manufacturing, Packaging or Shipping Problem	2	2
Mechanics Altered	1	1
Temperature Problem	1	1
Therapeutic or Diagnostic Output Failure	1	1
Torn Material	1	1
No Apparent Adverse Event	1	1
Material Too Soft/Flexible	1	1
Device Operates Differently Than Expected	1	1
Device Contaminated During Manufacture or Shipping	1	1
Fitting Problem	1	1
Incomplete or Missing Packaging	1	1
Dull, Blunt	1	1
Misfire	1	1
Split	1	1
Failure to Form Staple	1	1
Failure to Cut	1	1
Component Falling	1	1
Thermal Decomposition of Device	1	1
Complete Blockage	1	1
Crack	1	1
Disconnection	1	1
Material Disintegration	1	1
Entrapment of Device	1	1
Difficult to Insert	1	1
Loose or Intermittent Connection	1	1
Delivered as Unsterile Product	1	1
Device Emits Odor	1	1
Unintended Collision	1	1
Restricted Flow rate	1	1
Fluid/Blood Leak	1	1
Product Quality Problem	1	1
Material Too Rigid or Stiff	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	51	51
No Known Impact Or Consequence To Patient	25	25
Insufficient Information	23	23
Foreign Body In Patient	22	22
No Consequences Or Impact To Patient	9	9
No Information	4	4
Device Embedded In Tissue or Plaque	2	2
Burn(s)	2	2
Foreign Body Reaction	2	2
Hemorrhage/Bleeding	1	1
Laceration(s)	1	1
Nausea	1	1
Pain	1	1
Obstruction/Occlusion	1	1
Superficial (First Degree) Burn	1	1
Fluid Discharge	1	1
Death	1	1
Fever	1	1
Wound Dehiscence	1	1
Partial thickness (Second Degree) Burn	1	1

Recalls
Manufacturer		Recall Class	Date Posted
1	American Contract Systems	II	May-29-2020
2	American Contract Systems, Inc.	II	Jan-26-2024
3	American Contract Systems, Inc.	II	Oct-26-2023
4	American Contract Systems, Inc.	II	Sep-08-2022
5	American Contract Systems, Inc.	II	May-06-2022
6	Cardinal Health 200, LLC	II	Oct-10-2023
7	Customed, Inc	II	Sep-03-2015
8	Customed, Inc	I	Dec-16-2014
9	Customed, Inc	I	Aug-29-2014
10	MEDLINE INDUSTRIES, LP - Northfield	I	Feb-25-2024
11	MEDLINE INDUSTRIES, LP - Northfield	II	Aug-03-2023
12	MEDLINE INDUSTRIES, LP - Northfield	II	Jul-20-2023
13	MEDLINE INDUSTRIES, LP - Northfield	II	Feb-06-2023
14	MEDLINE INDUSTRIES, LP - Northfield	II	Jan-27-2023
15	MEDLINE INDUSTRIES, LP - SPT	II	Jul-27-2022
16	Medline Industries Inc	II	Jan-07-2021
17	Medline Industries Inc	II	Feb-11-2020
18	ROi CPS LLC	II	Apr-25-2023
19	ROi CPS LLC	II	Nov-23-2022
20	ROi CPS LLC	II	Jun-08-2022