TPLC - Total Product Life Cycle

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Premarket Reviews
Manufacturer	Decision
A2 MEDICAL SYSTEMS, LLC
	SUBSTANTIALLY EQUIVALENT	2
AESCULAP INC.
	SUBSTANTIALLY EQUIVALENT	1
DANNIK
	SUBSTANTIALLY EQUIVALENT	1
ETHICON ENDO SURGERY, LLC.
	SUBSTANTIALLY EQUIVALENT	1
M/S. MERIL ENDO SURGERY PRIVATE LIMITED
	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	1
TELEFLEX MEDICAL
	SUBSTANTIALLY EQUIVALENT	3

Device Problems	MDRs with this Device Problem	Events in those MDRs
Mechanics Altered	2674	2674
Failure to Form Staple	2478	2530
Mechanical Problem	1556	1556
Failure to Fire	1514	1514
Difficult to Open or Close	1122	1122
Break	863	863
Positioning Failure	679	679
Mechanical Jam	546	546
Detachment of Device or Device Component	526	526
Activation, Positioning or Separation Problem	415	415
Material Deformation	305	305
Device Slipped	232	232
Adverse Event Without Identified Device or Use Problem	212	212
Misfire	205	205
Firing Problem	186	186
Insufficient Information	166	166
Failure to Align	149	149
Device Fell	144	144
Failure to Advance	127	127
Fail-Safe Problem	123	123
Entrapment of Device	110	110
No Apparent Adverse Event	95	95
Display or Visual Feedback Problem	89	89
Unintended Ejection	73	73
Noise, Audible	70	70
Patient Device Interaction Problem	59	59
Material Fragmentation	57	57
Physical Resistance/Sticking	57	57
Loss of or Failure to Bond	50	50
Material Integrity Problem	49	49
Appropriate Term/Code Not Available	49	49
Migration	46	46
Delivered as Unsterile Product	41	41
Defective Device	38	38
Material Twisted/Bent	33	33
Difficult to Remove	33	33
Use of Device Problem	31	31
Component Missing	30	30
Device Dislodged or Dislocated	30	30
Difficult to Insert	29	29
Product Quality Problem	28	28
Tear, Rip or Hole in Device Packaging	28	28
Patient-Device Incompatibility	25	25
Activation Failure	25	25
Leak/Splash	23	23
Positioning Problem	22	22
Defective Component	21	21
Fracture	21	21
Difficult or Delayed Positioning	20	20
Premature Activation	18	18

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	7449	7449
No Consequences Or Impact To Patient	3680	3732
Insufficient Information	590	590
No Known Impact Or Consequence To Patient	296	296
Hemorrhage/Bleeding	239	239
No Information	160	160
No Code Available	127	127
Unspecified Tissue Injury	112	112
No Patient Involvement	110	110
Failure to Anastomose	63	63
Tissue Breakdown	63	63
Foreign Body In Patient	54	54
Pain	53	53
Tissue Damage	49	49
Blood Loss	49	49
Laceration(s)	29	29
Perforation of Vessels	25	25
Hematoma	22	22
Hypersensitivity/Allergic reaction	19	19
Injury	18	18
Unintended Radiation Exposure	18	18
Inflammation	16	16
Unspecified Infection	15	15
Fever	13	13
Device Embedded In Tissue or Plaque	13	13
Perforation	13	13
Abscess	12	12
Sepsis	11	11
Patient Problem/Medical Problem	10	10
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	10	10
Autoimmune Disorder	10	10
Not Applicable	10	10
Fistula	10	10
Anemia	9	9
Abdominal Distention	9	9
Abdominal Pain	9	9
Fluid Discharge	9	9
Failure of Implant	9	9
Death	9	9
Extreme Exhaustion	8	8
Rash	8	8
Confusion/ Disorientation	8	8
Post Operative Wound Infection	7	7
Fatigue	7	7
Wound Dehiscence	7	7
Peritonitis	6	6
Nausea	6	6
Cardiac Arrest	6	6
Cerebrospinal Fluid Leakage	5	5
Thrombus	5	5

Recalls
Manufacturer		Recall Class	Date Posted
1	Aesculap Implant Systems LLC	II	Sep-27-2021
2	Ethicon Endo-Surgery Inc	II	Dec-06-2019
3	Genicon, Inc.	II	Oct-30-2020
4	TELEFLEX LLC	II	May-30-2023
5	Teleflex Medical	II	Nov-19-2019