TPLC - Total Product Life Cycle

show TPLC since

Premarket Reviews
Manufacturer	Decision
A2 MEDICAL SYSTEMS, LLC
	SUBSTANTIALLY EQUIVALENT	2
AESCULAP, INC.
	SUBSTANTIALLY EQUIVALENT	1
ETHICON ENDO SURGERY, LLC
	SUBSTANTIALLY EQUIVALENT	1
HANGZHOU KANGJI MEDICAL INSTRUMENT CO., LTD.
	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	2336	2336
Failure to Form Staple	2271	2273
Failure to Fire	1679	1682
Mechanical Problem	1379	1379
Positioning Failure	801	805
Difficult to Open or Close	703	703
Break	537	538
Detachment of Device or Device Component	426	426
Mechanical Jam	390	391
Material Deformation	256	257
Device Slipped	182	182
Adverse Event Without Identified Device or Use Problem	181	181
Insufficient Information	175	175
Firing Problem	163	163
Activation, Positioning or Separation Problem	131	131
Failure to Align	122	122
Fail-Safe Problem	114	114
Entrapment of Device	107	111
No Apparent Adverse Event	105	105
Misfire	92	92
Display or Visual Feedback Problem	82	82
Unintended Ejection	70	71
Patient Device Interaction Problem	66	74
Noise, Audible	64	64
Delivered as Unsterile Product	56	56
Appropriate Term/Code Not Available	47	47
Migration	47	51
Material Integrity Problem	43	43
Material Fragmentation	37	38
Device Fell	35	35
Use of Device Problem	33	33
Failure to Advance	32	32
Product Quality Problem	30	30
Difficult to Insert	27	28
Fluid/Blood Leak	26	26
Component Missing	26	26
Physical Resistance/Sticking	25	25
Patient-Device Incompatibility	24	47
Device Dislodged or Dislocated	24	24
Defective Device	23	23
Difficult to Remove	22	22
Failure to Seal	20	20
Tear, Rip or Hole in Device Packaging	19	19
Component or Accessory Incompatibility	19	19
Difficult or Delayed Positioning	17	17
Positioning Problem	17	17
Fracture	16	16
Manufacturing, Packaging or Shipping Problem	15	15
Material Twisted/Bent	13	13
Activation Failure	13	13

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	8331	8339
No Consequences Or Impact To Patient	1291	1291
Insufficient Information	631	634
Hemorrhage/Bleeding	255	259
Unspecified Tissue Injury	113	113
Tissue Breakdown	80	80
No Information	69	69
No Patient Involvement	65	66
Failure to Anastomose	59	59
Foreign Body In Patient	52	56
No Code Available	51	51
No Known Impact Or Consequence To Patient	50	51
Pain	47	63
Laceration(s)	29	30
Tissue Damage	24	24
Perforation of Vessels	22	22
Hematoma	21	21
Unintended Radiation Exposure	19	19
Hypersensitivity/Allergic reaction	18	42
Blood Loss	14	14
Unspecified Infection	14	34
Fever	13	13
Inflammation	13	32
Abscess	12	12
Sepsis	11	11
Autoimmune Disorder	10	10
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	10	10
Anemia	10	10
Fistula	9	9
Device Embedded In Tissue or Plaque	9	13
Fluid Discharge	9	10
Abdominal Distention	9	33
Post Operative Wound Infection	8	8
Failure of Implant	8	11
Confusion/ Disorientation	8	8
Rash	8	27
Extreme Exhaustion	8	8
Exsanguination	8	8
Peritonitis	7	7
Abdominal Pain	7	7
Injury	6	6
Obstruction/Occlusion	6	6
Nausea	6	6
Wound Dehiscence	6	6
Patient Problem/Medical Problem	6	6
Cerebrospinal Fluid Leakage	5	5
Cardiac Arrest	5	5
Fatigue	5	6
Vomiting	5	5
Perforation	4	4

Recalls
Manufacturer		Recall Class	Date Posted
1	Aesculap Implant Systems LLC	II	Sep-27-2021
2	Genicon, Inc.	II	Oct-30-2020
3	TELEFLEX LLC	II	May-30-2023