TPLC - Total Product Life Cycle

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Device	gauze/sponge, internal, x-ray detectable
Regulation Description	Nonabsorbable gauze for internal use.
Product Code	GDY
Regulation Number	878.4450
Device Class	1

Device Problems	MDRs with this Device Problem	Events in those MDRs
Detachment of Device or Device Component	194	194
Material Fragmentation	154	154
Material Frayed	128	202
Component Missing	43	43
Material Separation	37	37
Material Disintegration	15	15
Material Integrity Problem	13	13
Manufacturing, Packaging or Shipping Problem	12	12
Device Misassembled During Manufacturing /Shipping	11	11
Delivered as Unsterile Product	10	13
Incorrect Measurement	9	9
Contamination	8	8
Adverse Event Without Identified Device or Use Problem	7	7
Contamination /Decontamination Problem	5	5
False Negative Result	4	4
Unraveled Material	4	4
Break	3	3
Nonstandard Device	3	3
Insufficient Device Problem Information	3	3
Device Contaminated During Manufacture or Shipping	3	3
Illegible Information	2	2
Separation Problem	2	2
Particulates	2	2
Physical Resistance/Sticking	2	2
Component Misassembled	2	2
Appropriate Device Problem Term/Code Not Available	2	2
No Apparent Adverse Event	2	2
Packaging Problem	2	2
Device Dislodged or Dislocated	2	2
Defective Device	2	2
Device Damaged Prior to Use	2	2
Fire	2	2
Material Protrusion/Extrusion	1	1
Protective Measures Problem	1	1
Lens (IOL), defective, problem not specified	1	1
Device Displays Incorrect Message	1	1
Separation Failure	1	1
Radiation Output Problem	1	1
Radiation Output Failure	1	1
Loose or Intermittent Connection	1	1
Misassembled	1	1
Difficult to Insert	1	1
Foreign material	1	1
Product Quality Problem	1	1
Unable to Obtain Readings	1	1
False Positive Result	1	1
Explanted	1	1
Entrapment of Device	1	1
Extra Components	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	596	673
Insufficient Information	92	94
Foreign Body In Patient	54	54
Unintended Radiation Exposure	10	10
Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available	5	5
Tissue Breakdown	5	5
Device Embedded In Tissue or Plaque	5	5
Hemorrhage/Blood Loss/Bleeding	4	4
Laceration(s)	2	2
Unspecified Infection	2	2
Inflammation	1	1
Skin Tears	1	1
No Known Impact Or Consequence To Patient	1	1
Pain	1	1

Recalls
Manufacturer		Recall Class	Date Posted
1	Argon Medical Devices, Inc	I	Jul-10-2026
2	Argon Medical Devices, Inc	II	Feb-04-2022
3	Carefree Surgical Specialties	II	Aug-08-2025
4	Covidien	II	Mar-21-2024
5	Cypress Medical Products LLC	II	Sep-14-2021