Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

New Search show TPLC since Back to Search Results
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 13 13

Device Problems MDRs with this Device Problem Events in those MDRs
Adverse Event Without Identified Device or Use Problem 242 242
Component Missing 3 3
Appropriate Term/Code Not Available 3 3
Incomplete or Missing Packaging 2 2
Volume Accuracy Problem 2 2
Material Separation 2 2
Material Split, Cut or Torn 2 2
Material Integrity Problem 2 2
Break 1 1
Crack 1 1
Device Markings/Labelling Problem 1 1
Material Rupture 1 1
Delivered as Unsterile Product 1 1
Product Quality Problem 1 1
Tear, Rip or Hole in Device Packaging 1 1
Detachment of Device or Device Component 1 1
Device Contamination with Chemical or Other Material 1 1
Device Contaminated During Manufacture or Shipping 1 1
Disconnection 1 1
Insufficient Information 1 1
Material Erosion 1 1
Manufacturing, Packaging or Shipping Problem 1 1
Microbial Contamination of Device 1 1
Contamination 1 1
Contamination /Decontamination Problem 1 1
Dull, Blunt 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 68 68
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
No Code Available 7 7
Foreign Body In Patient 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
Cramp(s) /Muscle Spasm(s) 2 2
Inflammation 2 2
Discomfort 2 2
Dysuria 2 2
Hypersensitivity/Allergic reaction 2 2
No Consequences Or Impact To Patient 2 2
Unspecified Infection 2 2
Peritonitis 1 1
Itching Sensation 1 1
Rash 1 1
Weakness 1 1
Malaise 1 1
No Information 1 1
Bowel Perforation 1 1
Urinary Retention 1 1
Disability 1 1
No Patient Involvement 1 1
Sepsis 1 1
Fatigue 1 1
Autoimmune Reaction 1 1
Perforation of Vessels 1 1
Unspecified Tissue Injury 1 1
Bacterial Infection 1 1
Patient Problem/Medical Problem 1 1
Fainting 1 1
Weight Changes 1 1
Therapeutic Effects, Unexpected 1 1
Urinary Frequency 1 1
Deformity/ Disfigurement 1 1

Recalls
Manufacturer Recall Class Date Posted
1 American Contract Systems, Inc. II Aug-07-2024
2 American Contract Systems, Inc. II Jan-26-2024
3 American Contract Systems, Inc. II Sep-08-2022
4 Boston Scientific Corporation II Apr-23-2021
5 Cardinal Health 200, LLC II Jun-06-2023
6 MEDLINE INDUSTRIES, LP - Northfield II Sep-11-2024
7 MEDLINE INDUSTRIES, LP - Northfield II Sep-06-2024
8 MEDLINE INDUSTRIES, LP - Northfield II Aug-22-2024
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
-
-