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
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	2

Device Problems	MDRs with this Device Problem	Events in those MDRs
Mechanics Altered	2128	2128
Failure to Form Staple	2055	2055
Failure to Fire	1354	1354
Mechanical Problem	1266	1266
Difficult to Open or Close	640	640
Positioning Failure	635	635
Break	518	518
Detachment of Device or Device Component	403	403
Mechanical Jam	315	315
Material Deformation	235	235
Adverse Event Without Identified Device or Use Problem	167	167
Device Slipped	164	164
Insufficient Information	154	154
Firing Problem	137	137
Activation, Positioning or Separation Problem	129	129
Failure to Align	115	115
Fail-Safe Problem	107	107
No Apparent Adverse Event	94	94
Entrapment of Device	88	88
Misfire	86	86
Display or Visual Feedback Problem	65	65
Unintended Ejection	63	63
Noise, Audible	61	61
Patient Device Interaction Problem	50	50
Migration	46	46
Appropriate Term/Code Not Available	44	44
Material Integrity Problem	40	40
Delivered as Unsterile Product	38	38
Material Fragmentation	36	36
Device Fell	32	32
Failure to Advance	32	32
Product Quality Problem	28	28
Use of Device Problem	27	27
Difficult to Insert	26	26
Component Missing	26	26
Difficult to Remove	21	21
Device Dislodged or Dislocated	21	21
Physical Resistance/Sticking	20	20
Tear, Rip or Hole in Device Packaging	19	19
Defective Device	19	19
Difficult or Delayed Positioning	17	17
Fracture	16	16
Manufacturing, Packaging or Shipping Problem	15	15
Positioning Problem	15	15
Component or Accessory Incompatibility	15	15
Patient-Device Incompatibility	14	14
Device Markings/Labelling Problem	12	12
Activation Failure	12	12
Material Twisted/Bent	12	12
Material Separation	11	11

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	7151	7151
No Consequences Or Impact To Patient	1291	1291
Insufficient Information	579	579
Hemorrhage/Bleeding	236	236
Unspecified Tissue Injury	112	112
No Information	69	69
No Patient Involvement	65	65
Tissue Breakdown	60	60
Failure to Anastomose	51	51
No Code Available	51	51
No Known Impact Or Consequence To Patient	50	50
Foreign Body In Patient	42	42
Pain	33	33
Laceration(s)	26	26
Tissue Damage	24	24
Perforation of Vessels	21	21
Hematoma	20	20
Unintended Radiation Exposure	18	18
Hypersensitivity/Allergic reaction	15	15
Blood Loss	14	14
Unspecified Infection	13	13
Inflammation	13	13
Abscess	11	11
Sepsis	11	11
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	10	10
Anemia	9	9
Fluid Discharge	9	9
Abdominal Distention	9	9
Fistula	9	9
Rash	8	8
Device Embedded In Tissue or Plaque	8	8
Post Operative Wound Infection	6	6
Injury	6	6
Wound Dehiscence	6	6
Patient Problem/Medical Problem	6	6
Abdominal Pain	6	6
Fever	5	5
Nausea	5	5
Cerebrospinal Fluid Leakage	5	5
Failure of Implant	5	5
Peritonitis	5	5
Cardiac Arrest	5	5
Vomiting	5	5
Obstruction/Occlusion	5	5
Dyspnea	4	4
Fatigue	4	4
Thrombosis/Thrombus	4	4
Perforation	4	4
Discomfort	4	4
Nerve Damage	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