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
TAIWAN SURGICAL CORPORATION
	SUBSTANTIALLY EQUIVALENT	1
TELEFLEX MEDICAL
	SUBSTANTIALLY EQUIVALENT	2

Device Problems	MDRs with this Device Problem	Events in those MDRs
Mechanics Altered	2391	2391
Failure to Form Staple	2164	2216
Mechanical Problem	1394	1394
Failure to Fire	1230	1230
Difficult to Open or Close	1055	1055
Break	842	842
Mechanical Jam	498	498
Detachment of Device or Device Component	489	489
Positioning Failure	483	483
Activation, Positioning or Separation Problem	414	414
Material Deformation	271	271
Device Slipped	214	214
Misfire	203	203
Adverse Event Without Identified Device or Use Problem	196	196
Firing Problem	170	170
Device Fell	142	142
Insufficient Information	139	139
Failure to Align	136	136
Failure to Advance	127	127
Fail-Safe Problem	115	115
Entrapment of Device	98	98
Display or Visual Feedback Problem	84	84
No Apparent Adverse Event	83	83
Unintended Ejection	72	72
Noise, Audible	67	67
Physical Resistance/Sticking	57	57
Material Fragmentation	55	55
Loss of or Failure to Bond	50	50
Patient Device Interaction Problem	49	49
Appropriate Term/Code Not Available	47	47
Material Integrity Problem	43	43
Migration	41	41
Defective Device	34	34
Difficult to Remove	33	33
Delivered as Unsterile Product	32	32
Material Twisted/Bent	31	31
Component Missing	30	30
Use of Device Problem	29	29
Difficult to Insert	28	28
Device Dislodged or Dislocated	27	27
Tear, Rip or Hole in Device Packaging	27	27
Product Quality Problem	27	27
Activation Failure	24	24
Leak/Splash	23	23
Positioning Problem	22	22
Fracture	21	21
Difficult or Delayed Positioning	20	20
Defective Component	19	19
Premature Activation	18	18
Therapeutic or Diagnostic Output Failure	16	16

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	6133	6133
No Consequences Or Impact To Patient	3680	3732
Insufficient Information	525	525
No Known Impact Or Consequence To Patient	296	296
Hemorrhage/Bleeding	207	207
No Information	160	160
No Code Available	127	127
No Patient Involvement	110	110
Unspecified Tissue Injury	108	108
Failure to Anastomose	61	61
Foreign Body In Patient	52	52
Blood Loss	49	49
Tissue Damage	49	49
Pain	41	41
Tissue Breakdown	40	40
Laceration(s)	23	23
Perforation of Vessels	23	23
Hematoma	21	21
Injury	18	18
Inflammation	16	16
Hypersensitivity/Allergic reaction	16	16
Unintended Radiation Exposure	15	15
Unspecified Infection	14	14
Perforation	13	13
Device Embedded In Tissue or Plaque	12	12
Abscess	10	10
Patient Problem/Medical Problem	10	10
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	10	10
Sepsis	10	10
Not Applicable	10	10
Fistula	10	10
Abdominal Distention	9	9
Anemia	9	9
Death	9	9
Fluid Discharge	9	9
Abdominal Pain	9	9
Rash	8	8
Failure of Implant	8	8
Post Operative Wound Infection	7	7
Wound Dehiscence	7	7
Fatigue	6	6
Cerebrospinal Fluid Leakage	5	5
Fever	5	5
Nerve Damage	5	5
Peritonitis	5	5
Vomiting	5	5
Obstruction/Occlusion	5	5
Hemostasis	5	5
Nausea	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