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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
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 CodeOHD
Regulation Number 884.1720
Device Class 2

MDR Year MDR Reports MDR Events
2021 222 222
2022 13 13
2023 6 6
2024 18 18
2025 15 15
2026 9 9

Device Problems MDRs with this Device Problem Events in those MDRs
Adverse Event Without Identified Device or Use Problem 231 231
Contamination /Decontamination Problem 7 7
Component Missing 5 5
Material Integrity Problem 5 5
Break 4 4
Fluid/Blood Leak 3 3
Appropriate Term/Code Not Available 3 3
Volume Accuracy Problem 2 2
Temperature Problem 2 2
Contamination 2 2
Crack 1 1
Disconnection 1 1
Nonstandard Device 1 1
Delivered as Unsterile Product 1 1
Material Puncture/Hole 1 1
Material Separation 1 1
Tear, Rip or Hole in Device Packaging 1 1
Dull, Blunt 1 1
Structural Problem 1 1
Contamination of Device Ingredient or Reagent 1 1
Activation, Positioning or Separation Problem 1 1
Detachment of Device or Device Component 1 1
Device Contaminated During Manufacture or Shipping 1 1
Insufficient Information 1 1
Material Split, Cut or Torn 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
Pain 187 187
Incontinence 144 144
Constipation 134 134
Dyspareunia 126 126
Insufficient Information 71 71
Abnormal Vaginal Discharge 50 50
Unspecified Mental, Emotional or Behavioural Problem 48 48
Erosion 38 38
No Clinical Signs, Symptoms or Conditions 32 32
Prolapse 11 11
Foreign Body In Patient 9 9
Urinary Tract Infection 7 7
Micturition Urgency 4 4
Injury 3 3
Discomfort 3 3
Depression 3 3
Hemorrhage/Bleeding 3 3
Hypersensitivity/Allergic reaction 2 2
Dysuria 2 2
Cramp(s) /Muscle Spasm(s) 2 2
Abdominal Pain 1 1
Unspecified Infection 1 1
Weight Changes 1 1
Fatigue 1 1
Urinary Incontinence 1 1
Bowel Perforation 1 1
Inflammation 1 1
Malaise 1 1
Itching Sensation 1 1
Burn(s) 1 1
Rash 1 1
Urinary Retention 1 1
Scar Tissue 1 1
Perforation of Vessels 1 1
Unspecified Tissue Injury 1 1
Bacterial Infection 1 1
Urinary Frequency 1 1
Fibrosis 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 May-07-2026
25 Medline Industries, LP II Apr-30-2026
26 Medline Industries, LP II Apr-17-2026
27 Medline Industries, LP II Apr-17-2026
28 Medline Industries, LP I Apr-07-2026
29 Medline Industries, LP II Feb-17-2026
30 Medline Industries, LP II Jan-28-2026
31 Medline Industries, LP II Jan-14-2026
32 Medline Industries, LP II Nov-14-2025
33 Medline Industries, LP I Nov-13-2025
34 ROi CPS LLC II Apr-25-2023
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