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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device guide, needle, surgical
Product CodeGDF
Regulation Number 878.4800
Device Class 1

MDR Year MDR Reports MDR Events
2019 13 13
2020 14 14
2021 9 9
2022 5 5
2023 13 13
2024 16 16

Device Problems MDRs with this Device Problem Events in those MDRs
Break 20 20
Device Contamination with Chemical or Other Material 8 8
Signal Artifact/Noise 7 7
Adverse Event Without Identified Device or Use Problem 7 7
Detachment of Device or Device Component 7 7
Device Markings/Labelling Problem 6 6
Difficult to Remove 5 5
Image Display Error/Artifact 4 4
Material Fragmentation 3 3
Migration or Expulsion of Device 2 2
Crack 2 2
Biocompatibility 2 2
Difficult to Advance 1 1
Device Fell 1 1
Gas/Air Leak 1 1
Material Separation 1 1
Migration 1 1
Failure to Advance 1 1
Nonstandard Device 1 1
Improper or Incorrect Procedure or Method 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 27 27
No Consequences Or Impact To Patient 14 14
Foreign Body In Patient 10 10
Insufficient Information 6 6
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 4 4
No Known Impact Or Consequence To Patient 4 4
No Patient Involvement 4 4
Injury 3 3
Pneumothorax 2 2
Pain 2 2
Unspecified Infection 1 1
Hyperplasia 1 1
Incontinence 1 1
Perforation of Vessels 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Advance Medical Designs, Inc. II Sep-09-2023
2 M.D.L. S.r.l. II Sep-20-2021
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