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TPLC
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Device
culdoscope (and accessories)
Product Code
HEW
Regulation Number
884.1640
Device Class
2
Premarket Reviews
Manufacturer
Decision
APPLIED MEDICAL RESOURCES
SUBSTANTIALLY EQUIVALENT
1
APPLIED MEDICAL RESOURCES CORP.
SUBSTANTIALLY EQUIVALENT
1
COOPER SURGICAL INC.
SUBSTANTIALLY EQUIVALENT
1
COOPERSURGICAL, INC.
SUBSTANTIALLY EQUIVALENT
2
J.SINGH INSTRUMENTS
SUBSTANTIALLY EQUIVALENT
1
LSI SOLUTIONS, INC.
SUBSTANTIALLY EQUIVALENT
1
SURGITOOLS PTY LTD.
SUBSTANTIALLY EQUIVALENT
1
MDR Year
MDR Reports
MDR Events
2014
2
2
2016
9
9
2017
15
15
2018
13
13
2019
29
29
2020
35
35
2021
14
14
2022
23
23
2023
18
18
2024
5
5
Device Problems
MDRs with this Device Problem
Events in those MDRs
Break
30
30
Melted
19
19
Detachment of Device or Device Component
17
17
Material Separation
8
8
Entrapment of Device
7
7
Adverse Event Without Identified Device or Use Problem
7
7
Inflation Problem
6
6
Sparking
5
5
Insufficient Information
5
5
Defective Device
5
5
Material Fragmentation
5
5
Leak/Splash
5
5
Material Rupture
4
4
Thermal Decomposition of Device
3
3
Overheating of Device
3
3
Poor Quality Image
3
3
Material Twisted/Bent
3
3
Improper or Incorrect Procedure or Method
3
3
Smoking
3
3
Component Missing
3
3
Material Puncture/Hole
2
2
Use of Device Problem
2
2
Device Dislodged or Dislocated
2
2
Material Split, Cut or Torn
2
2
Therapeutic or Diagnostic Output Failure
2
2
Product Quality Problem
2
2
Device Fell
2
2
Defective Component
2
2
Excess Flow or Over-Infusion
2
2
Nonstandard Device
2
2
Loose or Intermittent Connection
2
2
Mechanics Altered
1
1
Flaked
1
1
Difficult to Insert
1
1
Malposition of Device
1
1
Material Perforation
1
1
Microbial Contamination of Device
1
1
Fluid/Blood Leak
1
1
Mechanical Problem
1
1
Display or Visual Feedback Problem
1
1
Crack
1
1
Output Problem
1
1
Mechanical Jam
1
1
Unintended Movement
1
1
Arcing
1
1
Fitting Problem
1
1
Material Deformation
1
1
Material Integrity Problem
1
1
Fire
1
1
Material Disintegration
1
1
Burst Container or Vessel
1
1
Gas/Air Leak
1
1
No Display/Image
1
1
Disassembly
1
1
Appropriate Term/Code Not Available
1
1
Increase in Pressure
1
1
Contamination /Decontamination Problem
1
1
Patient Problems
MDRs with this Patient Problem
Events in those MDRs
No Known Impact Or Consequence To Patient
43
43
No Clinical Signs, Symptoms or Conditions
36
36
Insufficient Information
15
15
Laceration(s)
12
12
No Patient Involvement
11
11
Foreign Body In Patient
10
10
No Consequences Or Impact To Patient
9
9
Uterine Perforation
6
6
Hemorrhage/Bleeding
4
4
Device Embedded In Tissue or Plaque
4
4
No Information
3
3
Unspecified Infection
3
3
Burn(s)
2
2
Perforation
2
2
Bowel Perforation
1
1
Discomfort
1
1
Injury
1
1
Burn, Thermal
1
1
Adhesion(s)
1
1
Perforation of Vessels
1
1
Menstrual Irregularities
1
1
Pain
1
1
No Code Available
1
1
Unspecified Tissue Injury
1
1
Vascular Dissection
1
1
Recalls
Manufacturer
Recall Class
Date Posted
1
CooperSurgical, Inc.
II
May-26-2021
2
CooperSurgical, Inc.
II
Jul-15-2019
3
CooperSurgical, Inc.
II
Oct-11-2018
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