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	18	18
Break	15	15
Appropriate Term/Code Not Available	12	12
Component Missing	8	8
Packaging Problem	7	7
Contamination	7	7
Material Puncture/Hole	6	6
Contamination /Decontamination Problem	5	5
Device Contamination with Chemical or Other Material	4	4
Detachment of Device or Device Component	4	4
Material Fragmentation	4	4
Material Separation	3	3
Fire	3	3
Defective Device	3	3
Device Fell	3	3
Material Split, Cut or Torn	2	2
Adverse Event Without Identified Device or Use Problem	2	2
Unraveled Material	2	2
Material Frayed	2	2
Device Markings/Labelling Problem	2	2
Device Dislodged or Dislocated	2	2
Connection Problem	2	2
Incomplete or Missing Packaging	1	1
Failure to Form Staple	1	1
Compatibility Problem	1	1
Device Contaminated During Manufacture or Shipping	1	1
Manufacturing, Packaging or Shipping Problem	1	1
Mechanics Altered	1	1
Temperature Problem	1	1
Therapeutic or Diagnostic Output Failure	1	1
No Apparent Adverse Event	1	1
Loose or Intermittent Connection	1	1
Device Emits Odor	1	1
Unintended Collision	1	1
Use of Device Problem	1	1
Product Quality Problem	1	1
Material Too Rigid or Stiff	1	1
Fluid/Blood Leak	1	1
Thermal Decomposition of Device	1	1
Complete Blockage	1	1
Crack	1	1
Disconnection	1	1
Entrapment of Device	1	1
Material Too Soft/Flexible	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	57	57
Insufficient Information	25	25
Foreign Body In Patient	24	24
No Known Impact Or Consequence To Patient	13	13
No Consequences Or Impact To Patient	3	3
Foreign Body Reaction	2	2
Burn(s)	2	2
Superficial (First Degree) Burn	1	1
Wound Dehiscence	1	1
Nausea	1	1
No Information	1	1
Obstruction/Occlusion	1	1
Fever	1	1
Laceration(s)	1	1
Pain	1	1
Fluid Discharge	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	Sep-24-2024
3	American Contract Systems, Inc.	II	Aug-07-2024
4	American Contract Systems, Inc.	II	Jan-26-2024
5	American Contract Systems, Inc.	II	Oct-26-2023
6	American Contract Systems, Inc.	II	Sep-08-2022
7	American Contract Systems, Inc.	II	May-06-2022
8	Cardinal Health 200, LLC	II	Oct-10-2023
9	MEDLINE INDUSTRIES, LP - Northfield	II	Sep-11-2024
10	MEDLINE INDUSTRIES, LP - Northfield	II	Sep-06-2024
11	MEDLINE INDUSTRIES, LP - Northfield	II	Aug-28-2024
12	MEDLINE INDUSTRIES, LP - Northfield	II	Aug-22-2024
13	MEDLINE INDUSTRIES, LP - Northfield	II	Jun-28-2024
14	MEDLINE INDUSTRIES, LP - Northfield	I	Feb-25-2024
15	MEDLINE INDUSTRIES, LP - Northfield	II	Aug-03-2023
16	MEDLINE INDUSTRIES, LP - Northfield	II	Jul-20-2023
17	MEDLINE INDUSTRIES, LP - Northfield	II	Feb-06-2023
18	MEDLINE INDUSTRIES, LP - Northfield	II	Jan-27-2023
19	MEDLINE INDUSTRIES, LP - SPT	II	Jul-27-2022
20	Medline Industries Inc	II	Jan-07-2021
21	Medline Industries Inc	II	Feb-11-2020
22	ROi CPS LLC	II	Apr-25-2023
23	ROi CPS LLC	II	Nov-23-2022
24	ROi CPS LLC	II	Jun-08-2022