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TPLC
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Device
insufflator, hysteroscopic
Product Code
HIG
Regulation Number
884.1700
Device Class
2
Premarket Reviews
Manufacturer
Decision
GYRUS ACMI, INC.
SUBSTANTIALLY EQUIVALENT
1
1. K110852
DOLPHIN 3 FLUID MANAGEMENT SYSTEM
HOLOGIC, INC.
SUBSTANTIALLY EQUIVALENT
1
KARL STORZ SE & CO. KG
SUBSTANTIALLY EQUIVALENT
2
THERMEDX LLC
SUBSTANTIALLY EQUIVALENT
1
THERMEDX, LLC
SUBSTANTIALLY EQUIVALENT
3
W.O.M. WORLD OF MEDICINE AG
SUBSTANTIALLY EQUIVALENT
2
W.O.M. WORLD OF MEDICINE GMBH
SUBSTANTIALLY EQUIVALENT
2
MDR Year
MDR Reports
MDR Events
2014
9
9
2015
10
10
2016
10
10
2017
11
11
2018
10
10
2019
66
66
2020
31
31
2021
130
130
2022
66
66
2023
33
33
2024
14
14
Device Problems
MDRs with this Device Problem
Events in those MDRs
Material Fragmentation
132
132
Leak/Splash
37
37
Adverse Event Without Identified Device or Use Problem
25
25
Incorrect Measurement
17
17
Insufficient Information
15
15
Incorrect, Inadequate or Imprecise Result or Readings
13
13
Break
11
11
Detachment of Device or Device Component
11
11
Pressure Problem
10
10
Device Operates Differently Than Expected
9
9
Use of Device Problem
8
8
Defective Device
7
7
Infusion or Flow Problem
7
7
Output Problem
7
7
Fluid/Blood Leak
6
6
Display or Visual Feedback Problem
5
5
Defective Component
5
5
Improper Flow or Infusion
5
5
Volume Accuracy Problem
5
5
Improper or Incorrect Procedure or Method
4
4
Suction Problem
4
4
Device Displays Incorrect Message
4
4
Application Program Problem
4
4
Material Rupture
4
4
Material Separation
4
4
Mechanical Problem
4
4
Excess Flow or Over-Infusion
4
4
Nonstandard Device
4
4
Insufficient Flow or Under Infusion
3
3
Calibration Problem
2
2
Crack
2
2
Connection Problem
2
2
Inaccurate Dispensing
2
2
Protective Measures Problem
2
2
Therapeutic or Diagnostic Output Failure
2
2
Packaging Problem
2
2
Suction Failure
2
2
Loose or Intermittent Connection
2
2
Fracture
2
2
Burst Container or Vessel
2
2
Pumping Stopped
2
2
Shipping Damage or Problem
2
2
Device Inoperable
2
2
Mechanics Altered
2
2
Self-Activation or Keying
1
1
Material Puncture/Hole
1
1
Product Quality Problem
1
1
Misconnection
1
1
Tear, Rip or Hole in Device Packaging
1
1
Obstruction of Flow
1
1
Failure to Calibrate
1
1
Incorrect Or Inadequate Test Results
1
1
Low Readings
1
1
Failure to Align
1
1
Failure to Cut
1
1
Contamination
1
1
No Audible Alarm
1
1
Alarm Not Visible
1
1
False Negative Result
1
1
False Reading From Device Non-Compliance
1
1
Inability to Irrigate
1
1
Delivered as Unsterile Product
1
1
No Device Output
1
1
Increase in Pressure
1
1
Failure to Prime
1
1
Off-Label Use
1
1
Separation Problem
1
1
Lack of Effect
1
1
Power Problem
1
1
Material Split, Cut or Torn
1
1
Physical Resistance/Sticking
1
1
Incomplete or Inadequate Connection
1
1
No Apparent Adverse Event
1
1
Inadequate User Interface
1
1
Optical Problem
1
1
Output below Specifications
1
1
Difficult to Open or Close
1
1
Manufacturing, Packaging or Shipping Problem
1
1
Material Integrity Problem
1
1
Material Twisted/Bent
1
1
Communication or Transmission Problem
1
1
Other (for use when an appropriate device code cannot be identified)
1
1
Patient Problems
MDRs with this Patient Problem
Events in those MDRs
No Clinical Signs, Symptoms or Conditions
201
201
No Known Impact Or Consequence To Patient
55
55
No Consequences Or Impact To Patient
41
41
Insufficient Information
20
20
Hypervolemia
10
10
No Information
8
8
No Code Available
8
8
No Patient Involvement
8
8
Pulmonary Edema
6
6
Perforation
4
4
Unspecified Heart Problem
4
4
Cardiac Arrest
3
3
Swelling
3
3
Uterine Perforation
2
2
Loss of consciousness
2
2
Death
2
2
Pulmonary Embolism
2
2
Air Embolism
2
2
Edema
2
2
Extravasation
2
2
Hyponatremia
2
2
Unspecified Tissue Injury
2
2
Unspecified Kidney or Urinary Problem
1
1
Embolism/Embolus
1
1
Thrombosis/Thrombus
1
1
Unspecified Vascular Problem
1
1
Fever
1
1
Hyperventilation
1
1
Low Blood Pressure/ Hypotension
1
1
Laceration(s)
1
1
Internal Organ Perforation
1
1
Peritoneal Laceration(s)
1
1
Septic Shock
1
1
Airway Obstruction
1
1
Atrial Fibrillation
1
1
Exposure to Body Fluids
1
1
Bradycardia
1
1
Dehydration
1
1
Cardiopulmonary Arrest
1
1
Cyanosis
1
1
Pallor
1
1
Low Oxygen Saturation
1
1
Ischemic Heart Disease
1
1
Underdose
1
1
Blood Loss
1
1
Bronchospasm
1
1
Abdominal Distention
1
1
Electrolyte Imbalance
1
1
Bowel Perforation
1
1
Foreign Body In Patient
1
1
Heart Failure
1
1
Incomplete Induced Abortion
1
1
Brain Injury
1
1
Hypovolemia
1
1
Distress
1
1
Extubate
1
1
Recalls
Manufacturer
Recall Class
Date Posted
1
Thermedx LLC
II
Apr-20-2015
2
WOM World Of Medicine AG
II
Jan-05-2024
3
WOM World of Medicine AG
II
Sep-24-2021
4
WOM World of Medicine AG
II
Sep-30-2019
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