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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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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 CodeOHD
Regulation Number 884.1720
Device Class 2

MDR Year MDR Reports MDR Events
2020 5 5
2021 222 222
2022 13 13
2023 6 6
2024 18 18

Device Problems MDRs with this Device Problem Events in those MDRs
Adverse Event Without Identified Device or Use Problem 233 233
Appropriate Term/Code Not Available 3 3
Volume Accuracy Problem 2 2
Material Integrity Problem 2 2
Contamination 2 2
Component Missing 2 2
Disconnection 1 1
Device Contaminated During Manufacture or Shipping 1 1
Material Split, Cut or Torn 1 1
Break 1 1
Crack 1 1
Insufficient Information 1 1
Manufacturing, Packaging or Shipping Problem 1 1
Contamination /Decontamination 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
Detachment of Device or Device Component 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 69 69
Abnormal Vaginal Discharge 49 49
Unspecified Mental, Emotional or Behavioural Problem 47 47
Erosion 37 37
No Clinical Signs, Symptoms or Conditions 16 16
Prolapse 10 10
Foreign Body In Patient 7 7
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
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 Sep-24-2024
2 American Contract Systems, Inc. II Aug-07-2024
3 American Contract Systems, Inc. II Jan-26-2024
4 American Contract Systems, Inc. II Sep-08-2022
5 Boston Scientific Corporation II Apr-23-2021
6 Cardinal Health 200, LLC II Jan-15-2025
7 Cardinal Health 200, LLC II Jun-06-2023
8 MEDLINE INDUSTRIES, LP - Northfield II Dec-30-2024
9 MEDLINE INDUSTRIES, LP - Northfield II Dec-20-2024
10 MEDLINE INDUSTRIES, LP - Northfield II Dec-05-2024
11 MEDLINE INDUSTRIES, LP - Northfield II Oct-23-2024
12 MEDLINE INDUSTRIES, LP - Northfield II Sep-11-2024
13 MEDLINE INDUSTRIES, LP - Northfield II Sep-06-2024
14 MEDLINE INDUSTRIES, LP - Northfield II Aug-22-2024
15 MEDLINE INDUSTRIES, LP - Northfield I Feb-25-2024
16 MEDLINE INDUSTRIES, LP - Northfield II Aug-03-2023
17 MEDLINE INDUSTRIES, LP - Northfield II Jul-20-2023
18 MEDLINE INDUSTRIES, LP - Northfield II Feb-06-2023
19 ROi CPS LLC II Apr-25-2023
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