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TPLC
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show TPLC since
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Device
instrument, surgical, orthopedic, dc-powered motor and accessory/attachment
Product Code
KIJ
Regulation Number
878.4820
Device Class
1
Premarket Reviews
Manufacturer
Decision
INSURGICAL LLC
SUBSTANTIALLY EQUIVALENT
1
JEIL MEDICAL CORPORATION
SUBSTANTIALLY EQUIVALENT
2
1. K101563
SMARTO
2. K163308
SMARTO
MDR Year
MDR Reports
MDR Events
2014
36
36
2015
36
36
2016
11
11
2017
1
1
2018
1
1
2019
1
1
2020
1
1
2022
4
4
2023
6
6
2024
3
3
Device Problems
MDRs with this Device Problem
Events in those MDRs
Disassembly
19
19
Unintended Power Up
16
16
Device-Device Incompatibility
10
10
Overheating of Device
9
9
Battery Problem
9
9
Smoking
8
8
Fluid/Blood Leak
7
7
Unintended Movement
7
7
Leak/Splash
6
6
Break
4
4
Device Operates Differently Than Expected
3
3
Component Missing
3
3
Delayed Charge Time
3
3
Device Dislodged or Dislocated
2
2
Failure to Shut Off
2
2
Metal Shedding Debris
2
2
Adverse Event Without Identified Device or Use Problem
1
1
Insufficient Information
1
1
Device Fell
1
1
Failure to Clean Adequately
1
1
Failure to Fire
1
1
Unintended System Motion
1
1
Device Inoperable
1
1
Detachment Of Device Component
1
1
Component Falling
1
1
Bent
1
1
Fracture
1
1
Entrapment of Device
1
1
Unintended Ejection
1
1
Patient Problems
MDRs with this Patient Problem
Events in those MDRs
No Patient Involvement
53
53
No Known Impact Or Consequence To Patient
17
17
No Clinical Signs, Symptoms or Conditions
11
11
No Information
7
7
No Consequences Or Impact To Patient
4
4
Therapeutic Effects, Unexpected
2
2
Foreign Body In Patient
2
2
Device Embedded In Tissue or Plaque
1
1
Pain
1
1
Burn, Thermal
1
1
Insufficient Information
1
1
Recalls
Manufacturer
Recall Class
Date Posted
1
Stryker Instruments Div. of Stryker Corporation
II
Mar-10-2009
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