TPLC - Total Product Life Cycle

show TPLC since

Device	forceps, general & plastic surgery
Product Code	GEN
Regulation Number	878.4800
Device Class	1

Device Problems	MDRs with this Device Problem	Events in those MDRs
Break	39	39
Difficult to Open or Close	8	8
Detachment of Device or Device Component	6	6
Material Fragmentation	6	6
Mechanical Problem	4	4
Material Integrity Problem	4	4
Material Twisted/Bent	3	3
Material Separation	3	3
Improper or Incorrect Procedure or Method	3	3
Defective Device	2	2
Entrapment of Device	2	2
Fracture	2	2
Crack	2	2
Device Fell	2	2
Material Deformation	2	2
Device-Device Incompatibility	2	2
Adverse Event Without Identified Device or Use Problem	2	2
Output Problem	1	1
No Apparent Adverse Event	1	1
Insufficient Information	1	1
Appropriate Term/Code Not Available	1	1
Device Dislodged or Dislocated	1	1
Difficult or Delayed Separation	1	1
Mechanical Jam	1	1
Degraded	1	1
Disconnection	1	1
Device Reprocessing Problem	1	1
Inadequate Instructions for Healthcare Professional	1	1
Leak/Splash	1	1
Deformation Due to Compressive Stress	1	1
Contamination /Decontamination Problem	1	1
Product Quality Problem	1	1
Component Missing	1	1
Failure to Cut	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	47	47
Insufficient Information	9	9
Foreign Body In Patient	9	9
No Consequences Or Impact To Patient	9	9
No Known Impact Or Consequence To Patient	8	8
Device Embedded In Tissue or Plaque	4	4
Hemorrhage/Bleeding	3	3
Laceration(s)	2	2
Tooth Fracture	2	2
No Patient Involvement	2	2
No Information	1	1
No Code Available	1	1
Low Oxygen Saturation	1	1
Injury	1	1
Respiratory Distress Syndrome of Newborns	1	1
Low Blood Pressure/ Hypotension	1	1
Unspecified Infection	1	1

Recalls
Manufacturer		Recall Class	Date Posted
1	MEDLINE INDUSTRIES, LP - Northfield	II	Mar-29-2024