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TPLC
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Device
submucosal injection agent
Definition
Intended for use in gastrointestinal endoscopic procedures for submucosal lift of polyps, adenomas, early-stage cancers or other gastrointestinal mucosal lesions, prior to excision with a snare or endoscopic device.
Product Code
PLL
Regulation Number
876.1500
Device Class
2
Premarket Reviews
Manufacturer
Decision
BOSTON SCIENTIFIC
SUBSTANTIALLY EQUIVALENT
1
COSMO TECHNOLOGIES, LTD.
SUBSTANTIALLY EQUIVALENT
1
ENDOCLOT PLUS CO., LTD.
SUBSTANTIALLY EQUIVALENT
1
GI SUPPLY
SUBSTANTIALLY EQUIVALENT
1
GI SUPPLY, INC.
SUBSTANTIALLY EQUIVALENT
1
MICRO-TECH (NANJING) CO., LTD.
SUBSTANTIALLY EQUIVALENT
1
OVESCO ENDOSCOPY AG
SUBSTANTIALLY EQUIVALENT
1
THE STANDARD CO., LTD.
SUBSTANTIALLY EQUIVALENT
2
MDR Year
MDR Reports
MDR Events
2018
2
2
2019
3
3
2020
3
3
2022
36
36
2023
23
23
Device Problems
MDRs with this Device Problem
Events in those MDRs
Adverse Event Without Identified Device or Use Problem
51
51
Defective Device
5
5
Break
5
5
No Apparent Adverse Event
2
2
Nonstandard Device
2
2
Unsealed Device Packaging
1
1
Material Integrity Problem
1
1
Device Difficult to Setup or Prepare
1
1
Component Missing
1
1
Insufficient Flow or Under Infusion
1
1
Device Contamination with Chemical or Other Material
1
1
Detachment of Device or Device Component
1
1
Appropriate Term/Code Not Available
1
1
Material Fragmentation
1
1
Patient Problems
MDRs with this Patient Problem
Events in those MDRs
Granuloma
39
39
Fibrosis
8
8
No Clinical Signs, Symptoms or Conditions
7
7
Inflammation
6
6
Local Reaction
3
3
No Known Impact Or Consequence To Patient
3
3
Muscle Spasm(s)
3
3
Hemorrhage/Bleeding
3
3
No Consequences Or Impact To Patient
3
3
Bowel Perforation
2
2
Perforation
2
2
Obstruction/Occlusion
2
2
Insufficient Information
2
2
Abdominal Pain
1
1
Unspecified Infection
1
1
Arrhythmia
1
1
Reaction to Medicinal Component of Device
1
1
Fever
1
1
Scar Tissue
1
1
Dysphagia/ Odynophagia
1
1
Stenosis
1
1
Low Blood Pressure/ Hypotension
1
1
Tissue Breakdown
1
1
Recalls
Manufacturer
Recall Class
Date Posted
1
Boston Scientific Corporation
II
Nov-11-2022
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