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TPLC
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show TPLC since
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2024
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Device
table, operating-room, ac-powered
Product Code
FQO
Regulation Number
878.4960
Device Class
1
Premarket Reviews
Manufacturer
Decision
MOON SURGICAL
SUBSTANTIALLY EQUIVALENT
2
MDR Year
MDR Reports
MDR Events
2019
118
118
2020
97
97
2021
102
102
2022
125
125
2023
191
191
2024
106
106
Device Problems
MDRs with this Device Problem
Events in those MDRs
Unintended Movement
163
163
Use of Device Problem
95
95
Positioning Failure
64
64
Detachment of Device or Device Component
58
58
Insufficient Information
49
49
Mechanical Problem
30
30
Improper or Incorrect Procedure or Method
29
29
Positioning Problem
26
26
Device Fell
26
26
Electromagnetic Interference
23
23
Adverse Event Without Identified Device or Use Problem
22
22
Device Tipped Over
21
21
Unintended System Motion
20
20
Smoking
19
19
Communication or Transmission Problem
19
19
Fluid/Blood Leak
18
18
Device Sensing Problem
16
16
Circuit Failure
16
16
Break
14
14
Battery Problem
13
13
No Apparent Adverse Event
12
12
Device Handling Problem
11
11
Electrical Shorting
8
8
Difficult or Delayed Positioning
8
8
Structural Problem
7
7
Sharp Edges
7
7
Self-Activation or Keying
7
7
Fire
7
7
Naturally Worn
7
7
Key or Button Unresponsive/not Working
7
7
Noise, Audible
6
6
Unintended Collision
6
6
Sparking
6
6
Disconnection
6
6
Electrical /Electronic Property Problem
6
6
Device Slipped
6
6
Device Emits Odor
6
6
Complete Loss of Power
6
6
Fracture
6
6
Charging Problem
6
6
Patient Device Interaction Problem
6
6
Material Split, Cut or Torn
5
5
Intermittent Communication Failure
5
5
Physical Resistance/Sticking
5
5
Overheating of Device
5
5
Therapeutic or Diagnostic Output Failure
5
5
Moisture Damage
5
5
Mechanical Jam
4
4
Loose or Intermittent Connection
4
4
Power Problem
4
4
Patient Problems
MDRs with this Patient Problem
Events in those MDRs
No Clinical Signs, Symptoms or Conditions
425
425
No Known Impact Or Consequence To Patient
69
69
Insufficient Information
48
48
No Consequences Or Impact To Patient
46
46
Laceration(s)
30
30
Injury
26
26
Fall
19
19
Bone Fracture(s)
16
16
Electric Shock
11
11
Abrasion
11
11
Pain
8
8
No Information
7
7
Unspecified Tissue Injury
6
6
Limb Fracture
6
6
Head Injury
6
6
Bruise/Contusion
5
5
Burn(s)
5
5
Crushing Injury
5
5
No Code Available
5
5
Death
5
5
Localized Skin Lesion
3
3
No Patient Involvement
3
3
Hematoma
3
3
Hyperextension
3
3
Tooth Fracture
2
2
Cardiac Arrest
2
2
Multiple Fractures
2
2
Muscle Weakness
2
2
Nerve Damage
2
2
Discomfort
2
2
Unspecified Musculoskeletal problem
2
2
Nausea
2
2
Ulcer
2
2
Skin Tears
2
2
Low Blood Pressure/ Hypotension
2
2
Edema
1
1
Hematuria
1
1
Tissue Damage
1
1
Hemorrhage/Bleeding
1
1
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available
1
1
Patient Problem/Medical Problem
1
1
Device Embedded In Tissue or Plaque
1
1
Recalls
Manufacturer
Recall Class
Date Posted
1
Getinge Group Logistics America, LLC
II
Mar-23-2021
2
Getinge Usa Sales Inc
II
Jul-05-2024
3
Getinge Usa Sales Inc
II
Oct-04-2023
4
Getinge Usa Sales Inc
II
Nov-15-2022
5
IHB OPERATIONS B.V.
II
Dec-01-2023
6
Maquet Cardiovascular Us Sales, Llc
II
Oct-20-2020
7
Skytron, Div. The KMW Group, Inc
II
Jun-30-2022
8
Skytron, Div. The KMW Group, Inc
II
Jun-15-2021
9
Skytron, Div. The KMW Group, Inc
II
Mar-25-2020
10
Stryker Communications
II
Mar-24-2021
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