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TPLC
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show TPLC since
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2024
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Device
counter, sponge, surgical
Product Code
LWH
Regulation Number
880.2740
Device Class
1
MDR Year
MDR Reports
MDR Events
2019
66
66
2020
33
33
2021
35
35
2022
41
41
2023
39
39
2024
4
4
Device Problems
MDRs with this Device Problem
Events in those MDRs
False Positive Result
147
147
False Negative Result
65
65
Adverse Event Without Identified Device or Use Problem
5
5
Material Fragmentation
4
4
Device Displays Incorrect Message
4
4
Detachment of Device or Device Component
2
2
Device Sensing Problem
2
2
Defective Device
2
2
Insufficient Information
2
2
Material Deformation
2
2
Device Fell
1
1
Output Problem
1
1
Protective Measures Problem
1
1
Electrical Shorting
1
1
Electromagnetic Compatibility Problem
1
1
Inappropriate or Unexpected Reset
1
1
Loose or Intermittent Connection
1
1
Unsealed Device Packaging
1
1
Incorrect Interpretation of Signal
1
1
Material Separation
1
1
Component Missing
1
1
Patient Problems
MDRs with this Patient Problem
Events in those MDRs
No Clinical Signs, Symptoms or Conditions
95
95
No Information
43
43
No Consequences Or Impact To Patient
25
25
Insufficient Information
18
18
No Patient Involvement
16
16
Radiation Exposure, Unintended
11
11
Unintended Radiation Exposure
9
9
Foreign Body In Patient
6
6
Hemorrhage/Bleeding
2
2
Abnormal Vaginal Discharge
1
1
Foreign Body Reaction
1
1
Bone Fracture(s)
1
1
No Known Impact Or Consequence To Patient
1
1
Physical Asymmetry
1
1
Device Embedded In Tissue or Plaque
1
1
No Code Available
1
1
Unspecified Tissue Injury
1
1
Recalls
Manufacturer
Recall Class
Date Posted
1
Stryker Instruments Div. of Stryker Corporation
II
Jul-22-2022
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