TPLC - Total Product Life Cycle

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Device	accessories, cleaning brushes, for endoscope
Regulation Description	Endoscope and accessories.
Product Code	MNL
Regulation Number	876.1500
Device Class	1

Device Problems	MDRs with this Device Problem	Events in those MDRs
Break	235	235
Detachment of Device or Device Component	34	34
Material Separation	20	20
Difficult to Remove	17	17
Material Integrity Problem	17	17
Failure to Clean Adequately	17	19
Adverse Event Without Identified Device or Use Problem	16	16
Fracture	16	16
Device Reprocessing Problem	16	16
Entrapment of Device	12	12
Material Fragmentation	9	9
Use of Device Problem	8	8
Device Contaminated During Manufacture or Shipping	7	7
Failure to Disconnect	6	6
Material Frayed	6	6
Product Quality Problem	6	6
Mechanical Problem	5	5
Defective Device	5	5
Device Contamination with Chemical or Other Material	5	5
Inaccurate Information	5	5
Mechanical Jam	4	4
Partial Blockage	4	4
Degraded	3	3
Contamination	3	3
Difficult to Insert	2	2
Contamination /Decontamination Problem	2	2
Device Damaged by Another Device	2	2
Difficult to Advance	2	2
Device Dislodged or Dislocated	2	2
Problem with Sterilization	2	2
Suction Problem	2	2
Microbial Contamination of Device	2	2
Residue After Decontamination	2	2
Obstruction of Flow	1	1
Fungus in Device Environment	1	1
Improper or Incorrect Procedure or Method	1	1
Device Misassembled During Manufacturing /Shipping	1	1
Contamination of Device Ingredient or Reagent	1	1
Leak/Splash	1	1
Delivered as Unsterile Product	1	1
Device Emits Odor	1	1
Corroded	1	1
Material Disintegration	1	1
Naturally Worn	1	1
Improper Flow or Infusion	1	1
Manufacturing, Packaging or Shipping Problem	1	1
Material Deformation	1	1
No Apparent Adverse Event	1	1
Insufficient Information	1	1
Device Handling Problem	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	417	417
Foreign Body In Patient	7	7
Insufficient Information	7	9
Unspecified Infection	1	1
Hypersensitivity/Allergic reaction	1	1
Chemical Exposure	1	1
No Patient Involvement	1	1
Laceration(s)	1	1
Unspecified Tissue Injury	1	1

Recalls
Manufacturer		Recall Class	Date Posted
1	Healthmark Industries Co., Inc.	II	Jun-05-2025
2	MEDLINE INDUSTRIES, LP - Northfield	II	Jun-02-2022
3	Mckesson Medical-Surgical Inc. Corporate Office	II	Mar-19-2024
4	Mckesson Medical-Surgical Inc. Corporate Office	II	Aug-26-2022