TPLC - Total Product Life Cycle

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Premarket Reviews
Manufacturer	Decision
A2 MEDICAL SYSTEMS, LLC
	SUBSTANTIALLY EQUIVALENT	2
ETHICON ENDO SURGERY, LLC
	SUBSTANTIALLY EQUIVALENT	1
HANGZHOU KANGJI MEDICAL INSTRUMENT CO., LTD.
	SUBSTANTIALLY EQUIVALENT	1
MEDSCOPE BIOTECH CO., LTD.
	SUBSTANTIALLY EQUIVALENT	1
NEURAMEDICA, INC.
	SUBSTANTIALLY EQUIVALENT	1
SYNOVIS MICRO COMPANIES ALLIANCE A SUBSIDIARY OF BAXTER INT
	SUBSTANTIALLY EQUIVALENT	1
TAIWAN SURGICAL CORPORATION
	SUBSTANTIALLY EQUIVALENT	3
TELEFLEX MEDICAL
	SUBSTANTIALLY EQUIVALENT	3

Device Problems	MDRs with this Device Problem	Events in those MDRs
Mechanics Altered	2113	2113
Failure to Form Staple	2106	2108
Failure to Fire	1838	1842
Mechanical Problem	1245	1245
Positioning Failure	847	851
Difficult to Open or Close	609	609
Break	402	402
Detachment of Device or Device Component	352	352
Mechanical Jam	316	317
Material Deformation	242	243
Insufficient Information	188	188
Device Slipped	185	185
Adverse Event Without Identified Device or Use Problem	183	183
Firing Problem	179	179
No Apparent Adverse Event	120	120
Failure to Align	113	113
Fail-Safe Problem	110	110
Entrapment of Device	102	106
Unintended Ejection	70	71
Display or Visual Feedback Problem	64	64
Patient Device Interaction Problem	64	72
Delivered as Unsterile Product	61	61
Noise, Audible	59	59
Misfire	53	53
Migration	48	52
Material Integrity Problem	39	39
Activation, Positioning or Separation Problem	38	38
Fluid/Blood Leak	37	37
Use of Device Problem	35	35
Appropriate Term/Code Not Available	35	35
Failure to Seal	31	31
Difficult to Insert	29	30
Product Quality Problem	27	27
Material Fragmentation	27	28
Device Dislodged or Dislocated	27	27
Patient-Device Incompatibility	23	46
Difficult to Remove	22	22
Physical Resistance/Sticking	20	20
Device Fell	18	18
Defective Device	18	18
Component Missing	17	17
Component or Accessory Incompatibility	17	17
Fracture	16	16
Difficult or Delayed Positioning	15	15
Manufacturing, Packaging or Shipping Problem	15	15
Activation Failure	13	13
Device Markings/Labelling Problem	12	12
Material Twisted/Bent	11	11
Tear, Rip or Hole in Device Packaging	11	11
Failure to Eject	11	11

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	8896	8905
Insufficient Information	654	657
Hemorrhage/Bleeding	301	305
Unspecified Tissue Injury	116	116
Tissue Breakdown	110	110
Failure to Anastomose	61	61
Foreign Body In Patient	46	50
Pain	44	57
Laceration(s)	31	32
Hematoma	27	27
Perforation of Vessels	21	21
Unintended Radiation Exposure	20	20
Hypersensitivity/Allergic reaction	18	42
Unspecified Infection	17	37
Inflammation	13	32
Abscess	12	12
Fever	12	12
Abdominal Distention	11	35
Fistula	11	11
Autoimmune Disorder	10	10
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	10	10
Post Operative Wound Infection	9	9
Sepsis	9	9
Fluid Discharge	9	10
Failure of Implant	8	11
Exsanguination	8	8
Rash	8	27
Extreme Exhaustion	8	8
Confusion/ Disorientation	8	8
Anemia	7	7
Abdominal Pain	7	7
Device Embedded In Tissue or Plaque	6	10
Vomiting	6	6
Nausea	6	6
Wound Dehiscence	6	6
Cerebrospinal Fluid Leakage	5	5
Vascular Dissection	5	5
Fatigue	5	6
Perforation	5	5
Cardiac Arrest	5	5
Discomfort	4	4
Hematuria	4	4
Dyspnea	4	9
Low Blood Pressure/ Hypotension	4	4
Nerve Damage	4	4
Thrombosis/Thrombus	4	5
Obstruction/Occlusion	4	4
Unspecified Kidney or Urinary Problem	4	4
Peritonitis	4	4
Swelling/ Edema	3	8

Recalls
Manufacturer		Recall Class	Date Posted
1	Aesculap Implant Systems LLC	II	Sep-27-2021
2	TELEFLEX LLC	II	May-30-2023