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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
2019 17 17
2020 5 5
2021 222 222
2022 13 13
2023 6 6
2024 12 12

Device Problems MDRs with this Device Problem Events in those MDRs
Adverse Event Without Identified Device or Use Problem 241 241
Appropriate Term/Code Not Available 3 3
Component Missing 3 3
Incomplete or Missing Packaging 2 2
Material Split, Cut or Torn 2 2
Material Integrity Problem 2 2
Material Separation 2 2
Volume Accuracy Problem 2 2
Microbial Contamination of Device 1 1
Insufficient Information 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
Manufacturing, Packaging or Shipping Problem 1 1
Break 1 1
Contamination 1 1
Crack 1 1
Disconnection 1 1
Material Erosion 1 1
Delivered as Unsterile Product 1 1
Product Quality Problem 1 1
Material Rupture 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
Pain 191 191
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
No Clinical Signs, Symptoms or Conditions 13 13
Prolapse 10 10
Urinary Tract Infection 9 9
Foreign Body In Patient 7 7
No Code Available 7 7
Hemorrhage/Bleeding 5 5
Micturition Urgency 4 4
Injury 4 4
No Known Impact Or Consequence To Patient 4 4
Depression 3 3
Obstruction/Occlusion 3 3
Abdominal Pain 3 3
Unspecified Infection 2 2
Inflammation 2 2
Hypersensitivity/Allergic reaction 2 2
Discomfort 2 2
No Consequences Or Impact To Patient 2 2
Dysuria 2 2
Cramp(s) /Muscle Spasm(s) 2 2
Unspecified Tissue Injury 1 1
No Information 1 1
Peritonitis 1 1
Urinary Frequency 1 1
Perforation of Vessels 1 1
Weakness 1 1
Disability 1 1
Malaise 1 1
Deformity/ Disfigurement 1 1
Patient Problem/Medical Problem 1 1
Weight Changes 1 1
No Patient Involvement 1 1
Bowel Perforation 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

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 MEDLINE INDUSTRIES, LP - Northfield I Feb-25-2024
6 MEDLINE INDUSTRIES, LP - Northfield II Aug-03-2023
7 MEDLINE INDUSTRIES, LP - Northfield II Jul-20-2023
8 MEDLINE INDUSTRIES, LP - Northfield II Feb-06-2023
9 ROi CPS LLC II Apr-25-2023
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