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
Failure to Form Staple	1974	1976
Mechanics Altered	1955	1955
Failure to Fire	1652	1655
Mechanical Problem	1164	1164
Positioning Failure	818	822
Difficult to Open or Close	556	556
Break	379	379
Detachment of Device or Device Component	334	334
Mechanical Jam	289	290
Material Deformation	226	227
Insufficient Information	170	170
Adverse Event Without Identified Device or Use Problem	160	160
Device Slipped	158	158
Firing Problem	144	144
Failure to Align	112	112
No Apparent Adverse Event	107	107
Fail-Safe Problem	105	105
Entrapment of Device	92	96
Unintended Ejection	69	70
Display or Visual Feedback Problem	63	63
Patient Device Interaction Problem	61	69
Noise, Audible	54	54
Delivered as Unsterile Product	54	54
Migration	47	51
Misfire	47	47
Material Integrity Problem	37	37
Activation, Positioning or Separation Problem	35	35
Use of Device Problem	34	34
Appropriate Term/Code Not Available	31	31
Fluid/Blood Leak	28	28
Difficult to Insert	27	28
Material Fragmentation	27	28
Product Quality Problem	26	26
Device Dislodged or Dislocated	23	23
Patient-Device Incompatibility	22	45
Failure to Seal	21	21
Physical Resistance/Sticking	18	18
Device Fell	18	18
Component Missing	17	17
Component or Accessory Incompatibility	17	17
Difficult to Remove	17	17
Fracture	16	16
Manufacturing, Packaging or Shipping Problem	15	15
Defective Device	15	15
Difficult or Delayed Positioning	15	15
Activation Failure	13	13
Device Markings/Labelling Problem	12	12
Failure to Eject	11	11
Tear, Rip or Hole in Device Packaging	11	11
Unsealed Device Packaging	10	10

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	8239	8247
Insufficient Information	607	610
Hemorrhage/Bleeding	258	262
Unspecified Tissue Injury	110	110
Tissue Breakdown	85	85
Failure to Anastomose	56	56
Pain	42	55
Foreign Body In Patient	41	45
Laceration(s)	28	29
Unintended Radiation Exposure	19	19
Perforation of Vessels	17	17
Hematoma	17	17
Hypersensitivity/Allergic reaction	15	39
Unspecified Infection	13	33
Fever	12	12
Abscess	11	11
Inflammation	11	30
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	10	10
Autoimmune Disorder	10	10
Sepsis	9	9
Fluid Discharge	9	10
Abdominal Distention	9	33
Failure of Implant	8	11
Extreme Exhaustion	8	8
Exsanguination	8	8
Rash	8	27
Confusion/ Disorientation	8	8
Post Operative Wound Infection	8	8
Abdominal Pain	7	7
Fistula	7	7
Anemia	7	7
Nausea	6	6
Device Embedded In Tissue or Plaque	6	10
Fatigue	5	6
Cerebrospinal Fluid Leakage	5	5
Vomiting	5	5
Wound Dehiscence	5	5
Cardiac Arrest	5	5
Unspecified Kidney or Urinary Problem	4	4
Hematuria	4	4
Dyspnea	4	9
Discomfort	4	4
Low Blood Pressure/ Hypotension	4	4
Nerve Damage	4	4
Thrombosis/Thrombus	4	5
Obstruction/Occlusion	4	4
Peritonitis	4	4
Renal Impairment	3	3
Swelling/ Edema	3	8
Hernia	3	3

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