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	539	539
Device-Device Incompatibility	90	90
Material Integrity Problem	83	83
Mechanical Problem	23	23
Material Fragmentation	14	14
Compatibility Problem	12	12
Use of Device Problem	12	12
Material Deformation	12	12
Material Twisted/Bent	11	11
Contamination /Decontamination Problem	9	9
Device Slipped	6	6
Crack	6	6
No Apparent Adverse Event	6	6
Entrapment of Device	5	5
Difficult to Open or Close	5	5
Insufficient Information	4	4
Material Discolored	4	4
Appropriate Term/Code Not Available	4	4
Product Quality Problem	3	3
Fracture	3	3
Component Missing	2	2
Detachment of Device or Device Component	2	2
Output Problem	1	1
Physical Resistance/Sticking	1	1
Defective Component	1	1
Failure to Clean Adequately	1	1
Failure to Align	1	1
Failure to Cut	1	1
Adverse Event Without Identified Device or Use Problem	1	1
Residue After Decontamination	1	1
Nonstandard Device	1	1
Unexpected Therapeutic Results	1	1
Human-Device Interface Problem	1	1
Noise, Audible	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	647	647
No Consequences Or Impact To Patient	66	66
Insufficient Information	39	39
No Patient Involvement	35	35
Foreign Body In Patient	7	7
No Known Impact Or Consequence To Patient	5	5
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	4	4
No Code Available	3	3
Vascular Dissection	1	1
Perforation	1	1
Osteopenia/ Osteoporosis	1	1
Burn(s)	1	1
Needle Stick/Puncture	1	1
Arteriosclerosis/ Atherosclerosis	1	1
Tissue Damage	1	1
Hemorrhage/Bleeding	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