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	35	35
Difficult to Open or Close	8	8
Material Fragmentation	7	7
Detachment of Device or Device Component	5	5
Mechanical Problem	3	3
Material Integrity Problem	3	3
Fracture	3	3
Improper or Incorrect Procedure or Method	3	3
Device-Device Incompatibility	2	2
Entrapment of Device	2	2
Crack	2	2
Defective Device	2	2
Adverse Event Without Identified Device or Use Problem	2	2
Material Deformation	2	2
Disconnection	1	1
Leak/Splash	1	1
Output Problem	1	1
Insufficient Information	1	1
Device Fell	1	1
Inadequate Instructions for Healthcare Professional	1	1
Contamination /Decontamination Problem	1	1
Degraded	1	1
Material Twisted/Bent	1	1
Failure to Cut	1	1
Difficult or Delayed Separation	1	1
Product Quality Problem	1	1
Material Separation	1	1
No Apparent Adverse Event	1	1
Device Reprocessing Problem	1	1
Deformation Due to Compressive Stress	1	1
Mechanical Jam	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	52	52
Insufficient Information	11	11
Foreign Body In Patient	7	7
Hemorrhage/Bleeding	4	4
No Consequences Or Impact To Patient	4	4
Laceration(s)	3	3
Low Blood Pressure/ Hypotension	3	3
Tooth Fracture	2	2
Pericardial Effusion	2	2
Device Embedded In Tissue or Plaque	2	2
Unspecified Infection	1	1
No Code Available	1	1
Vascular Dissection	1	1
No Known Impact Or Consequence To Patient	1	1
Injury	1	1
No Patient Involvement	1	1
Perforation of Vessels	1	1
Respiratory Distress Syndrome of Newborns	1	1
Low Oxygen Saturation	1	1
Unintended Radiation Exposure	1	1

Recalls
Manufacturer		Recall Class	Date Posted
1	MEDLINE INDUSTRIES, LP - Northfield	II	Dec-23-2024
2	MEDLINE INDUSTRIES, LP - Northfield	II	Mar-29-2024