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TPLC
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show TPLC since
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Device
cannula, manipulator/injector, uterine
Product Code
LKF
Regulation Number
884.4530
Device Class
2
Premarket Reviews
Manufacturer
Decision
BEIJING HANGTIAN KADI TECHNOLOGY R&D INSTITUTE
SUBSTANTIALLY EQUIVALENT
1
CATHETER RESEARCH, INC.
SUBSTANTIALLY EQUIVALENT
1
CLEARPATH SURGICAL, INC.
SUBSTANTIALLY EQUIVALENT
1
CLINICAL INNOVATIONS, LLC
SUBSTANTIALLY EQUIVALENT
1
CONMED CORPORATION
SUBSTANTIALLY EQUIVALENT
2
COOK INCORPORATED
SUBSTANTIALLY EQUIVALENT
5
COOPER SURGICAL, INC.
SUBSTANTIALLY EQUIVALENT
1
COOPERSURGICAL, INC
SUBSTANTIALLY EQUIVALENT
1
COOPERSURGICAL, INC.
SUBSTANTIALLY EQUIVALENT
2
CROSSBAY MEDICAL, INC.
SUBSTANTIALLY EQUIVALENT
1
ENDOCONTROL
SUBSTANTIALLY EQUIVALENT
1
FEMASYS INC.
SUBSTANTIALLY EQUIVALENT
5
GYNETECH PTY. LTD.
SUBSTANTIALLY EQUIVALENT
2
KRONNER PROTOTYPES, INC.
SUBSTANTIALLY EQUIVALENT
1
OBG PRODUCTS
SUBSTANTIALLY EQUIVALENT
1
PANPAC MEDICAL CORPORATION
SUBSTANTIALLY EQUIVALENT
4
REJONI, INC.
SUBSTANTIALLY EQUIVALENT
1
STERLING MEDICAL INC
SUBSTANTIALLY EQUIVALENT
1
THE O R COMPANY PTY LTD
SUBSTANTIALLY EQUIVALENT
2
MDR Year
MDR Reports
MDR Events
2014
45
45
2015
53
53
2016
62
62
2017
64
64
2018
23
23
2019
76
76
2020
119
119
2021
188
188
2022
101
101
2023
88
88
2024
86
86
Device Problems
MDRs with this Device Problem
Events in those MDRs
Detachment of Device or Device Component
175
175
Break
147
147
Unintended Movement
84
84
Inflation Problem
81
81
Material Separation
79
79
Material Fragmentation
78
78
Detachment Of Device Component
55
55
Material Rupture
32
32
Deflation Problem
24
24
Failure to Deflate
20
20
Material Puncture/Hole
17
17
Insufficient Information
16
16
Component Missing
12
12
Improper or Incorrect Procedure or Method
12
12
Leak/Splash
12
12
Device Operates Differently Than Expected
11
11
Structural Problem
10
10
Hole In Material
10
10
Material Protrusion/Extrusion
8
8
Therapeutic or Diagnostic Output Failure
8
8
Adverse Event Without Identified Device or Use Problem
7
7
Device Dislodged or Dislocated
7
7
Component Falling
7
7
Loose or Intermittent Connection
6
6
Fluid/Blood Leak
6
6
Burst Container or Vessel
6
6
Device Slipped
6
6
Gas/Air Leak
6
6
Melted
6
6
Difficult to Remove
6
6
Torn Material
5
5
Malposition of Device
5
5
Unintended Deflation
5
5
Fracture
5
5
Defective Device
5
5
Defective Component
5
5
Use of Device Problem
5
5
Material Perforation
5
5
Human-Device Interface Problem
5
5
Disconnection
4
4
Entrapment of Device
4
4
Output Problem
4
4
Physical Resistance/Sticking
4
4
Migration or Expulsion of Device
3
3
Peeled/Delaminated
3
3
Material Split, Cut or Torn
3
3
Mechanical Problem
3
3
Bent
3
3
Appropriate Term/Code Not Available
3
3
Material Twisted/Bent
3
3
Patient Problems
MDRs with this Patient Problem
Events in those MDRs
No Clinical Signs, Symptoms or Conditions
353
353
No Known Impact Or Consequence To Patient
189
189
No Consequences Or Impact To Patient
109
109
Insufficient Information
77
77
Foreign Body In Patient
71
71
Uterine Perforation
23
23
No Code Available
21
21
No Information
21
21
Device Embedded In Tissue or Plaque
12
12
Laceration(s)
9
9
No Patient Involvement
6
6
Injury
5
5
Abdominal Pain
4
4
Perforation
4
4
Bowel Perforation
3
3
Hemorrhage/Bleeding
3
3
Fever
3
3
Death
2
2
Abnormal Vaginal Discharge
2
2
Obstruction/Occlusion
2
2
Rupture
2
2
Needle Stick/Puncture
2
2
Abscess
2
2
Pain
2
2
Embolus
1
1
Low Blood Pressure/ Hypotension
1
1
Internal Organ Perforation
1
1
Low Oxygen Saturation
1
1
Bacterial Infection
1
1
Skin Tears
1
1
Tissue Damage
1
1
Hypoxia
1
1
Unspecified Tissue Injury
1
1
Discomfort
1
1
Joint Swelling
1
1
Rash
1
1
Pelvic Inflammatory Disease
1
1
Foreign Body Reaction
1
1
Foreign body, removal of
1
1
Adhesion(s)
1
1
Test Result
1
1
Unspecified Gastrointestinal Problem
1
1
Unspecified Infection
1
1
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available
1
1
Air Embolism
1
1
Nonresorbable materials, unretrieved in body
1
1
Recalls
Manufacturer
Recall Class
Date Posted
1
Clinical Innovations, LLC
II
May-26-2020
2
Cooper Surgical, Inc.
II
Nov-26-2012
3
CooperSurgical, Inc.
II
Dec-06-2023
4
CooperSurgical, Inc.
II
Jun-08-2015
5
CooperSurgical, Inc.
II
Sep-05-2014
6
CooperSurgical, Inc.
II
Jun-11-2014
7
Mckesson Medical-Surgical Inc. Corporate Office
II
Aug-26-2022
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