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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
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 9 9

Device Problems MDRs with this Device Problem Events in those MDRs
Adverse Event Without Identified Device or Use Problem 248 248
Torn Material 7 7
Appropriate Term/Code Not Available 4 4
Component Missing 3 3
Incomplete or Missing Packaging 2 2
Break 2 2
Product Quality Problem 2 2
Material Separation 2 2
Volume Accuracy Problem 2 2
Material Split, Cut or Torn 2 2
Insufficient Information 2 2
Manufacturing, Packaging or Shipping Problem 2 2
Material Deformation 1 1
Microbial Contamination of Device 1 1
Material Rupture 1 1
Contamination 1 1
Crack 1 1
Disconnection 1 1
Material Erosion 1 1
Delivered as Unsterile Product 1 1
Tear, Rip or Hole in Device Packaging 1 1
Dull, Blunt 1 1
Contamination /Decontamination Problem 1 1
Detachment of Device or Device Component 1 1
Device Markings/Labelling Problem 1 1
Device Contamination with Chemical or Other Material 1 1
Device Contaminated During Manufacture or Shipping 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 67 67
Abnormal Vaginal Discharge 49 49
Unspecified Mental, Emotional or Behavioural Problem 47 47
Erosion 39 39
Prolapse 11 11
No Clinical Signs, Symptoms or Conditions 11 11
No Consequences Or Impact To Patient 10 10
Urinary Tract Infection 9 9
No Information 7 7
No Code Available 7 7
No Known Impact Or Consequence To Patient 6 6
Hemorrhage/Bleeding 6 6
Foreign Body In Patient 6 6
Injury 5 5
Micturition Urgency 4 4
Unspecified Infection 4 4
Abdominal Pain 3 3
Depression 3 3
Obstruction/Occlusion 3 3
Discomfort 2 2
Inflammation 2 2
Hypersensitivity/Allergic reaction 2 2
Dysuria 2 2
Cramp(s) /Muscle Spasm(s) 2 2
Unspecified Tissue Injury 1 1
Rash 1 1
Sepsis 1 1
Therapeutic Effects, Unexpected 1 1
Urinary Retention 1 1
Itching Sensation 1 1
Autoimmune Reaction 1 1
Bacterial Infection 1 1
Fainting 1 1
Fatigue 1 1
Patient Problem/Medical Problem 1 1
Weight Changes 1 1
No Patient Involvement 1 1
Bowel Perforation 1 1
Disability 1 1
Malaise 1 1
Deformity/ Disfigurement 1 1
Peritonitis 1 1
Urinary Frequency 1 1
Perforation of Vessels 1 1
Weakness 1 1

Recalls
Manufacturer Recall Class Date Posted
1 American Contract Systems, Inc. II Jan-26-2024
2 American Contract Systems, Inc. II Sep-08-2022
3 Boston Scientific Corporation II Apr-23-2021
4 Cardinal Health 200, LLC II Jun-06-2023
5 Customed, Inc II Apr-14-2016
6 Customed, Inc II Sep-03-2015
7 Customed, Inc I Dec-16-2014
8 Customed, Inc I Aug-29-2014
9 MEDLINE INDUSTRIES, LP - Northfield I Feb-25-2024
10 MEDLINE INDUSTRIES, LP - Northfield II Aug-03-2023
11 MEDLINE INDUSTRIES, LP - Northfield II Jul-20-2023
12 MEDLINE INDUSTRIES, LP - Northfield II Feb-06-2023
13 ROi CPS LLC II Apr-25-2023
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