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TPLC
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show TPLC since
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Device
forceps, general & plastic surgery
Product Code
GEN
Regulation Number
878.4800
Device Class
1
MDR Year
MDR Reports
MDR Events
2019
18
18
2020
6
6
2021
20
20
2022
18
18
2023
25
25
2024
13
13
Device Problems
MDRs with this Device Problem
Events in those MDRs
Break
41
41
Difficult to Open or Close
8
8
Material Fragmentation
6
6
Detachment of Device or Device Component
6
6
Mechanical Problem
4
4
Material Integrity Problem
4
4
Material Twisted/Bent
3
3
Improper or Incorrect Procedure or Method
3
3
Material Separation
3
3
Fracture
3
3
Material Deformation
2
2
Crack
2
2
Device Fell
2
2
Adverse Event Without Identified Device or Use Problem
2
2
Device-Device Incompatibility
2
2
Entrapment of Device
2
2
Defective Device
2
2
Difficult or Delayed Separation
1
1
Insufficient Information
1
1
Contamination /Decontamination Problem
1
1
Inadequate Instructions for Healthcare Professional
1
1
Degraded
1
1
Component Missing
1
1
Failure to Cut
1
1
Deformation Due to Compressive Stress
1
1
Mechanical Jam
1
1
Leak/Splash
1
1
Disconnection
1
1
Output Problem
1
1
No Apparent Adverse Event
1
1
Product Quality Problem
1
1
Appropriate Term/Code Not Available
1
1
Device Dislodged or Dislocated
1
1
Device Reprocessing Problem
1
1
Patient Problems
MDRs with this Patient Problem
Events in those MDRs
No Clinical Signs, Symptoms or Conditions
49
49
Foreign Body In Patient
9
9
Insufficient Information
9
9
No Consequences Or Impact To Patient
9
9
No Known Impact Or Consequence To Patient
8
8
Device Embedded In Tissue or Plaque
4
4
Laceration(s)
3
3
Hemorrhage/Bleeding
3
3
Tooth Fracture
2
2
No Patient Involvement
2
2
Low Blood Pressure/ Hypotension
2
2
Unspecified Infection
1
1
No Code Available
1
1
No Information
1
1
Pericardial Effusion
1
1
Injury
1
1
Respiratory Distress Syndrome of Newborns
1
1
Low Oxygen Saturation
1
1
Unintended Radiation Exposure
1
1
Recalls
Manufacturer
Recall Class
Date Posted
1
MEDLINE INDUSTRIES, LP - Northfield
II
Mar-29-2024
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