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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 51 51

Device Problems MDRs with this Device Problem Events in those MDRs
Adverse Event Without Identified Device or Use Problem 231 231
Component Missing 9 9
Material Integrity Problem 7 7
Fluid/Blood Leak 7 7
Break 6 6
Unsealed Device Packaging 5 5
Contamination /Decontamination Problem 5 5
Material Frayed 3 3
Material Split, Cut or Torn 3 3
Appropriate Device Problem Term/Code Not Available 3 3
Dull, Blunt 3 3
Volume Accuracy Problem 2 2
Material Puncture/Hole 2 2
Corroded 2 2
Premature Activation 2 2
Temperature Problem 2 2
Leak/Splash 1 1
Device Alarm System 1 1
Crack 1 1
Complete Blockage 1 1
Material Disintegration 1 1
Unclear Information 1 1
Smoking 1 1
Contamination 1 1
Material Fragmentation 1 1
Device Misassembled During Manufacturing /Shipping 1 1
Insufficient Device Problem Information 1 1
Structural Problem 1 1
Material Separation 1 1
Nonstandard Device 1 1
Connection Problem 1 1
Component Incompatible 1 1
Loss of or Failure to Bond 1 1
Extra Components 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
No Clinical Signs, Symptoms or Conditions 74 74
Insufficient Information 71 71
Abnormal Vaginal Discharge 50 50
Unspecified Mental, Emotional or Behavioural Problem 48 48
Erosion 38 38
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/Blood Loss/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
Intraoperative Cardiac Injury 1 1
Fatigue 1 1
Urinary Incontinence 1 1
Bowel Perforation 1 1
Inflammation 1 1
Malaise 1 1
Itching Sensation 1 1
Urinary Frequency / Polyuria 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
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 Sep-03-2026
9 Cardinal Health 200, LLC II Jan-15-2025
10 Cardinal Health 200, LLC II Jun-06-2023
11 MEDLINE INDUSTRIES, LP - Northfield II Apr-17-2025
12 MEDLINE INDUSTRIES, LP - Northfield II Mar-25-2025
13 MEDLINE INDUSTRIES, LP - Northfield II Mar-14-2025
14 MEDLINE INDUSTRIES, LP - Northfield II Dec-30-2024
15 MEDLINE INDUSTRIES, LP - Northfield II Dec-20-2024
16 MEDLINE INDUSTRIES, LP - Northfield II Dec-05-2024
17 MEDLINE INDUSTRIES, LP - Northfield II Oct-23-2024
18 MEDLINE INDUSTRIES, LP - Northfield II Sep-11-2024
19 MEDLINE INDUSTRIES, LP - Northfield II Sep-06-2024
20 MEDLINE INDUSTRIES, LP - Northfield II Aug-22-2024
21 MEDLINE INDUSTRIES, LP - Northfield I Feb-25-2024
22 MEDLINE INDUSTRIES, LP - Northfield II Aug-03-2023
23 MEDLINE INDUSTRIES, LP - Northfield II Jul-20-2023
24 MEDLINE INDUSTRIES, LP - Northfield II Feb-06-2023
25 Medline Industries, LP II Aug-26-2026
26 Medline Industries, LP II Jul-23-2026
27 Medline Industries, LP II Jun-17-2026
28 Medline Industries, LP II Jun-12-2026
29 Medline Industries, LP II May-07-2026
30 Medline Industries, LP II Apr-30-2026
31 Medline Industries, LP II Apr-17-2026
32 Medline Industries, LP II Apr-17-2026
33 Medline Industries, LP I Apr-07-2026
34 Medline Industries, LP II Feb-17-2026
35 Medline Industries, LP II Jan-28-2026
36 Medline Industries, LP II Jan-14-2026
37 Medline Industries, LP II Nov-14-2025
38 Medline Industries, LP I Nov-13-2025
39 ROi CPS LLC II Apr-25-2023
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