TPLC - Total Product Life Cycle

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Device	forceps
Regulation Description	Manual surgical instrument for general use.
Product Code	HTD
Regulation Number	878.4800
Device Class	1

Device Problems	MDRs with this Device Problem	Events in those MDRs
Break	589	590
Device-Device Incompatibility	97	97
Material Integrity Problem	91	91
Mechanical Problem	29	29
Material Deformation	23	23
Compatibility Problem	17	18
Material Twisted/Bent	17	17
Use of Device Problem	14	14
Crack	13	13
Material Fragmentation	12	12
Mechanical Jam	12	12
Difficult to Open or Close	9	9
No Apparent Adverse Event	7	7
Contamination /Decontamination Problem	6	6
Device Slipped	5	5
Entrapment of Device	5	5
Material Discolored	5	5
Insufficient Device Problem Information	4	4
Product Quality Problem	3	3
Fracture	3	3
Corroded	3	3
Detachment of Device or Device Component	2	2
Appropriate Device Problem Term/Code Not Available	2	2
Physical Resistance/Sticking	1	1
Defective Component	1	1
Contamination	1	1
Component Missing	1	1
Failure to Align	1	1
Adverse Event Without Identified Device or Use Problem	1	1
Material Separation	1	1
Device Reprocessing Problem	1	1
Nonstandard Device	1	1
Human-Device Interface Problem	1	1
Dull, Blunt	1	1
Noise, Audible	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	814	816
Insufficient Information	50	50
Foreign Body In Patient	7	7
Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available	4	4
Vascular Dissection	1	1
Perforation	1	1
Burn(s)	1	1
Needle Stick/Puncture	1	1
Hemorrhage/Blood Loss/Bleeding	1	1
Arteriosclerosis/ Atherosclerosis	1	1
No Consequences Or Impact To Patient	1	1

Recalls
Manufacturer		Recall Class	Date Posted
1	Aesculap Inc	II	Mar-11-2025
2	Sklar Instruments	II	Jan-16-2025
3	Stradis Medical, LLC dba Stradis Healthcare	II	Aug-18-2022