TPLC - Total Product Life Cycle

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Premarket Reviews
Manufacturer	Decision
BIEN-AIR SURGERY SA
	SUBSTANTIALLY EQUIVALENT	1
MEDTRONIC POWERED SURGICAL SOLUTIONS
	SUBSTANTIALLY EQUIVALENT	1
SAESHIN PRECISION CO., LTD.
	SUBSTANTIALLY EQUIVALENT	2
THE ANSPACH EFFORT, INC.
	SUBSTANTIALLY EQUIVALENT	1
ZETHON LTD
	SUBSTANTIALLY EQUIVALENT	1

Device Problems	MDRs with this Device Problem	Events in those MDRs
Excessive Heating	2038	2038
Vibration	955	955
Overheating of Device	863	863
Device Damaged by Another Device	440	440
Unintended System Motion	429	429
Detachment of Device or Device Component	423	423
Device Alarm System	276	276
Complete Loss of Power	257	257
Noise, Audible	175	175
Break	156	156
Material Twisted/Bent	156	156
Device-Device Incompatibility	144	144
Fail-Safe Did Not Operate	134	134
Material Fragmentation	110	110
Appropriate Term/Code Not Available	101	101
Mechanical Jam	58	58
Material Frayed	47	47
Leak/Splash	44	44
Separation Problem	42	42
Output below Specifications	39	39
Fail-Safe Problem	33	33
Premature Separation	31	31
Fracture	31	31
Difficult or Delayed Separation	27	27
Device Slipped	24	24
Mechanical Problem	24	24
Fluid/Blood Leak	22	22
Device Reprocessing Problem	15	15
No Apparent Adverse Event	15	15
Environmental Particulates	15	15
Electrical /Electronic Property Problem	12	12
Adverse Event Without Identified Device or Use Problem	10	10
Unintended Movement	9	9
Component Missing	9	9
Intermittent Loss of Power	8	8
Dull, Blunt	7	7
Device Markings/Labelling Problem	7	7
Connection Problem	6	6
Physical Resistance/Sticking	5	5
Separation Failure	5	5
Device Remains Activated	4	4
Corroded	4	4
Manufacturing, Packaging or Shipping Problem	4	4
Material Rupture	4	4
Component or Accessory Incompatibility	3	3
Self-Activation or Keying	3	3
Naturally Worn	3	3
Power Problem	3	3
Device Fell	3	3
Retraction Problem	3	3

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	2681	2681
No Consequences Or Impact To Patient	2298	2298
No Known Impact Or Consequence To Patient	548	548
Insufficient Information	18	18
Burn(s)	14	14
Foreign Body In Patient	6	6
Unspecified Tissue Injury	5	5
Brain Injury	3	3
Burn, Thermal	3	3
Tissue Damage	3	3
Full thickness (Third Degree) Burn	3	3
Superficial (First Degree) Burn	2	2
Failure of Implant	2	2
Perforation	2	2
Injury	2	2
Patient Problem/Medical Problem	1	1
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	1	1
No Code Available	1	1
No Information	1	1
Chemical Exposure	1	1
Post Traumatic Wound Infection	1	1
No Patient Involvement	1	1
Peroneal Nerve Palsy	1	1
Aneurysm	1	1
Hemorrhage/Bleeding	1	1
Device Embedded In Tissue or Plaque	1	1
Unintended Radiation Exposure	1	1

Recalls
Manufacturer		Recall Class	Date Posted
1	The Anspach Effort, Inc.	II	Jan-07-2023