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TPLC
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show TPLC since
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Device
endoscopic retrograde cholangiopancreatography (ercp) cannula
Definition
To identify stones, tumors, or narrowing in the biliary tree.
Product Code
ODD
Regulation Number
876.1500
Device Class
2
Premarket Reviews
Manufacturer
Decision
STERIS CORPORATION
SUBSTANTIALLY EQUIVALENT
1
WILSON-COOK MEDICAL INC.
SUBSTANTIALLY EQUIVALENT
1
1. K171989
Classic ERCP Catheter and Huibregtse-Katon ERCP Ca
...
MDR Year
MDR Reports
MDR Events
2015
1
1
2016
2
2
2017
2
2
2018
13
13
2019
5
5
2020
11
11
2021
8
8
2022
11
11
2023
15
15
2024
7
7
Device Problems
MDRs with this Device Problem
Events in those MDRs
Adverse Event Without Identified Device or Use Problem
29
29
Fluid/Blood Leak
10
10
Difficult to Advance
6
6
Device Contamination with Chemical or Other Material
4
4
Break
4
4
Packaging Problem
3
3
Device Fell
3
3
Insufficient Information
2
2
Patient Device Interaction Problem
2
2
Detachment of Device or Device Component
2
2
Material Deformation
2
2
Unintended Movement
1
1
Improper Flow or Infusion
1
1
Device Contaminated During Manufacture or Shipping
1
1
Contamination
1
1
Disconnection
1
1
Material Disintegration
1
1
Leak/Splash
1
1
Loose or Intermittent Connection
1
1
Peeled/Delaminated
1
1
Improper or Incorrect Procedure or Method
1
1
Device Contamination with Body Fluid
1
1
Tear, Rip or Hole in Device Packaging
1
1
Physical Resistance/Sticking
1
1
Appropriate Term/Code Not Available
1
1
Patient Problems
MDRs with this Patient Problem
Events in those MDRs
No Clinical Signs, Symptoms or Conditions
18
18
Pancreatitis
14
14
Perforation
8
8
No Known Impact Or Consequence To Patient
7
7
Inflammation
6
6
No Consequences Or Impact To Patient
6
6
Exposure to Body Fluids
5
5
Insufficient Information
3
3
Device Embedded In Tissue or Plaque
2
2
No Code Available
2
2
Unspecified Hepatic or Biliary Problem
2
2
Hemorrhage/Bleeding
2
2
Hypoxia
2
2
Injury
2
2
Sepsis
2
2
Pneumonia
1
1
Chemical Exposure
1
1
No Patient Involvement
1
1
Intraoperative Pain
1
1
Conjunctivitis
1
1
Failure to Anastomose
1
1
Abdominal Pain
1
1
Abscess
1
1
Adult Respiratory Distress Syndrome
1
1
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