TPLC - Total Product Life Cycle

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Device	gynecological laparoscopic kit
Regulation Description	Gynecologic laparoscope 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	OHD
Regulation Number	884.1720
Device Class	2

Device Problems	MDRs with this Device Problem	Events in those MDRs
Adverse Event Without Identified Device or Use Problem	233	233
Contamination /Decontamination Problem	7	7
Break	4	4
Material Integrity Problem	4	4
Appropriate Term/Code Not Available	3	3
Volume Accuracy Problem	2	2
Contamination	2	2
Component Missing	2	2
Temperature Problem	2	2
Disconnection	1	1
Activation, Positioning or Separation Problem	1	1
Device Contaminated During Manufacture or Shipping	1	1
Material Split, Cut or Torn	1	1
Crack	1	1
Insufficient Information	1	1
Manufacturing, Packaging or Shipping Problem	1	1
Delivered as Unsterile Product	1	1
Material Rupture	1	1
Product Quality Problem	1	1
Material Separation	1	1
Tear, Rip or Hole in Device Packaging	1	1
Contamination of Device Ingredient or Reagent	1	1
Detachment of Device or Device Component	1	1
Nonstandard Device	1	1
Dull, Blunt	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
Pain	187	187
Incontinence	144	144
Constipation	134	134
Dyspareunia	125	125
Insufficient Information	72	72
Abnormal Vaginal Discharge	49	49
Unspecified Mental, Emotional or Behavioural Problem	47	47
Erosion	37	37
No Clinical Signs, Symptoms or Conditions	26	26
Prolapse	10	10
Foreign Body In Patient	8	8
Urinary Tract Infection	7	7
Micturition Urgency	4	4
Injury	3	3
Depression	3	3
Hemorrhage/Bleeding	3	3
Hypersensitivity/Allergic reaction	2	2
Dysuria	2	2
Cramp(s) /Muscle Spasm(s)	2	2
Discomfort	2	2
Unspecified Infection	1	1
Weight Changes	1	1
No Code Available	1	1
Fatigue	1	1
Bowel Perforation	1	1
Inflammation	1	1
Malaise	1	1
Itching Sensation	1	1
Burn(s)	1	1
No Patient Involvement	1	1
Urinary Retention	1	1
Unspecified Tissue Injury	1	1
Perforation of Vessels	1	1
Bacterial Infection	1	1
Urinary Frequency	1	1

Recalls
Manufacturer		Recall Class	Date Posted
1	American Contract Systems Inc	II	Aug-28-2025
2	American Contract Systems Inc.	II	Oct-16-2025
3	American Contract Systems, Inc.	II	Sep-24-2024
4	American Contract Systems, Inc.	II	Aug-07-2024
5	American Contract Systems, Inc.	II	Jan-26-2024
6	American Contract Systems, Inc.	II	Sep-08-2022
7	Boston Scientific Corporation	II	Apr-23-2021
8	Cardinal Health 200, LLC	II	Jan-15-2025
9	Cardinal Health 200, LLC	II	Jun-06-2023
10	MEDLINE INDUSTRIES, LP - Northfield	II	Apr-17-2025
11	MEDLINE INDUSTRIES, LP - Northfield	II	Mar-25-2025
12	MEDLINE INDUSTRIES, LP - Northfield	II	Mar-14-2025
13	MEDLINE INDUSTRIES, LP - Northfield	II	Dec-30-2024
14	MEDLINE INDUSTRIES, LP - Northfield	II	Dec-20-2024
15	MEDLINE INDUSTRIES, LP - Northfield	II	Dec-05-2024
16	MEDLINE INDUSTRIES, LP - Northfield	II	Oct-23-2024
17	MEDLINE INDUSTRIES, LP - Northfield	II	Sep-11-2024
18	MEDLINE INDUSTRIES, LP - Northfield	II	Sep-06-2024
19	MEDLINE INDUSTRIES, LP - Northfield	II	Aug-22-2024
20	MEDLINE INDUSTRIES, LP - Northfield	I	Feb-25-2024
21	MEDLINE INDUSTRIES, LP - Northfield	II	Aug-03-2023
22	MEDLINE INDUSTRIES, LP - Northfield	II	Jul-20-2023
23	MEDLINE INDUSTRIES, LP - Northfield	II	Feb-06-2023
24	Medline Industries, LP	II	Nov-14-2025
25	Medline Industries, LP	I	Nov-13-2025
26	ROi CPS LLC	II	Apr-25-2023