TPLC - Total Product Life Cycle

• Device: gynecological laparoscopic 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: OHD
• Regulation Number: 884.1720
• Device Class: 2

MDR Year	MDR Reports	MDR Events
2014	6	6
2016	3	3
2017	3	3
2018	7	7
2019	17	17
2020	5	5
2021	222	222
2022	13	13
2023	6	6
2024	13	13

Device Problems	MDRs with this Device Problem	Events in those MDRs
Adverse Event Without Identified Device or Use Problem	249	249
Torn Material	7	7
Appropriate Term/Code Not Available	4	4
Component Missing	3	3
Material Split, Cut or Torn	2	2
Break	2	2
Volume Accuracy Problem	2	2
Incomplete or Missing Packaging	2	2
Insufficient Information	2	2
Manufacturing, Packaging or Shipping Problem	2	2
Material Integrity Problem	2	2
Product Quality Problem	2	2
Material Separation	2	2
Disconnection	1	1
Device Contaminated During Manufacture or Shipping	1	1
Crack	1	1
Device Markings/Labelling Problem	1	1
Material Erosion	1	1
Contamination	1	1
Microbial Contamination of Device	1	1
Contamination /Decontamination Problem	1	1
Delivered as Unsterile Product	1	1
Material Rupture	1	1
Material Deformation	1	1
Tear, Rip or Hole in Device Packaging	1	1
Detachment of Device or Device Component	1	1
Device Contamination with Chemical or Other Material	1	1
Dull, Blunt	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
Pain	193	193
Incontinence	144	144
Constipation	134	134
Dyspareunia	125	125
Insufficient Information	68	68
Abnormal Vaginal Discharge	49	49
Unspecified Mental, Emotional or Behavioural Problem	47	47
Erosion	39	39
No Clinical Signs, Symptoms or Conditions	13	13
Prolapse	11	11
No Consequences Or Impact To Patient	10	10
Urinary Tract Infection	9	9
No Code Available	7	7
No Information	7	7
Foreign Body In Patient	7	7
Hemorrhage/Bleeding	6	6
No Known Impact Or Consequence To Patient	6	6
Injury	5	5
Unspecified Infection	4	4
Micturition Urgency	4	4
Depression	3	3
Obstruction/Occlusion	3	3
Abdominal Pain	3	3
Cramp(s) /Muscle Spasm(s)	2	2
Discomfort	2	2
Inflammation	2	2
Dysuria	2	2
Hypersensitivity/Allergic reaction	2	2
Peritonitis	1	1
Rash	1	1
Weakness	1	1
Itching Sensation	1	1
Malaise	1	1
Urinary Retention	1	1
No Patient Involvement	1	1
Bowel Perforation	1	1
Disability	1	1
Sepsis	1	1
Autoimmune Reaction	1	1
Perforation of Vessels	1	1
Unspecified Tissue Injury	1	1
Bacterial Infection	1	1
Fatigue	1	1
Fainting	1	1
Therapeutic Effects, Unexpected	1	1
Patient Problem/Medical Problem	1	1
Urinary Frequency	1	1
Deformity/ Disfigurement	1	1
Weight Changes	1	1

Recalls
Manufacturer		Recall Class	Date Posted
1	American Contract Systems, Inc.	II	Aug-07-2024
2	American Contract Systems, Inc.	II	Jan-26-2024
3	American Contract Systems, Inc.	II	Sep-08-2022
4	Boston Scientific Corporation	II	Apr-23-2021
5	Cardinal Health 200, LLC	II	Jun-06-2023
6	Customed, Inc	II	Apr-14-2016
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	II	Sep-11-2024
11	MEDLINE INDUSTRIES, LP - Northfield	II	Sep-06-2024
12	MEDLINE INDUSTRIES, LP - Northfield	II	Aug-22-2024
13	MEDLINE INDUSTRIES, LP - Northfield	I	Feb-25-2024
14	MEDLINE INDUSTRIES, LP - Northfield	II	Aug-03-2023
15	MEDLINE INDUSTRIES, LP - Northfield	II	Jul-20-2023
16	MEDLINE INDUSTRIES, LP - Northfield	II	Feb-06-2023
17	ROi CPS LLC	II	Apr-25-2023