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TPLC
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show TPLC since
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2024
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Device
dislodger, stone, basket, ureteral, metal
Product Code
FFL
Regulation Number
876.4680
Device Class
2
Premarket Reviews
Manufacturer
Decision
CALCULA TECHNOLOGIES, INC
SUBSTANTIALLY EQUIVALENT
1
PERCUTANEOUS SYSTEMS, INC.
SUBSTANTIALLY EQUIVALENT
1
THS INTERNATIONAL, INC. D/B/A ACCORDION MEDICAL
SUBSTANTIALLY EQUIVALENT
1
MDR Year
MDR Reports
MDR Events
2014
71
71
2015
79
79
2016
88
88
2017
517
517
2018
428
428
2019
351
351
2020
375
375
2021
358
358
2022
426
426
2023
593
593
2024
149
149
Device Problems
MDRs with this Device Problem
Events in those MDRs
Difficult to Open or Close
1411
1411
Break
950
950
Material Separation
203
203
Detachment of Device or Device Component
192
192
Device Operates Differently Than Expected
117
117
Material Deformation
110
110
Fracture
97
97
Adverse Event Without Identified Device or Use Problem
97
97
Material Twisted/Bent
72
72
Material Split, Cut or Torn
67
67
Device Damaged Prior to Use
59
59
Detachment Of Device Component
53
53
Difficult to Remove
30
30
Device Contaminated During Manufacture or Shipping
29
29
Material Fragmentation
28
28
Difficult to Fold, Unfold or Collapse
24
24
Difficult or Delayed Positioning
23
23
Device Contamination with Chemical or Other Material
22
22
Tear, Rip or Hole in Device Packaging
21
21
Loss of or Failure to Bond
20
20
Mechanical Problem
20
20
Defective Device
19
19
Deformation Due to Compressive Stress
19
19
Unsealed Device Packaging
15
15
Mechanical Jam
12
12
Loose or Intermittent Connection
12
12
Device Inoperable
12
12
Component Missing
11
11
Use of Device Problem
10
10
Appropriate Term/Code Not Available
10
10
Device Operational Issue
10
10
Kinked
10
10
Nonstandard Device
10
10
Device Packaging Compromised
10
10
Physical Resistance/Sticking
10
10
Entrapment of Device
9
9
Bent
9
9
Contamination /Decontamination Problem
9
9
Material Frayed
8
8
Disconnection
8
8
Torn Material
8
8
Off-Label Use
8
8
Retraction Problem
7
7
Improper or Incorrect Procedure or Method
7
7
Unintended Collision
6
6
Packaging Problem
5
5
Difficult to Advance
5
5
Material Rupture
5
5
Component Falling
4
4
Insufficient Information
4
4
Solder Joint Fracture
4
4
Structural Problem
4
4
Device Dislodged or Dislocated
3
3
Activation, Positioning or Separation Problem
3
3
Component Misassembled
3
3
Migration or Expulsion of Device
3
3
Device Or Device Fragments Location Unknown
3
3
Sharp Edges
3
3
Accessory Incompatible
3
3
Sticking
3
3
Peeled/Delaminated
3
3
Device-Device Incompatibility
2
2
Separation Failure
2
2
Device Handling Problem
2
2
Material Protrusion/Extrusion
2
2
Out-Of-Box Failure
2
2
Difficult to Insert
2
2
Component(s), broken
2
2
Separation Problem
2
2
Stretched
2
2
Split
2
2
Failure to Advance
2
2
Misassembled
2
2
Connection Problem
2
2
Unraveled Material
2
2
Therapeutic or Diagnostic Output Failure
2
2
Activation Problem
1
1
Incorrect Measurement
1
1
Degraded
1
1
Coiled
1
1
Product Quality Problem
1
1
Migration
1
1
Material Integrity Problem
1
1
Contamination
1
1
Device Fell
1
1
Failure to Capture
1
1
Defective Component
1
1
Material Discolored
1
1
Failure to Unfold or Unwrap
1
1
Device Slipped
1
1
Microbial Contamination of Device
1
1
Crack
1
1
Naturally Worn
1
1
Material Too Soft/Flexible
1
1
Collapse
1
1
Device Markings/Labelling Problem
1
1
Positioning Problem
1
1
Device Disinfection Or Sterilization Issue
1
1
Mechanics Altered
1
1
Flaked
1
1
Patient Problems
MDRs with this Patient Problem
Events in those MDRs
No Clinical Signs, Symptoms or Conditions
1339
1339
No Consequences Or Impact To Patient
1291
1291
No Known Impact Or Consequence To Patient
392
392
No Patient Involvement
188
188
Foreign Body In Patient
93
93
Insufficient Information
88
88
No Information
51
51
No Code Available
35
35
Device Embedded In Tissue or Plaque
32
32
Urinary Tract Infection
27
27
Perforation
20
20
Pain
15
15
Sepsis
13
13
Foreign body, removal of
11
11
Injury
8
8
Hemorrhage/Bleeding
8
8
Inflammation
7
7
Obstruction/Occlusion
7
7
Hematuria
6
6
Swelling/ Edema
5
5
Laceration(s)
5
5
Renal Failure
5
5
Tissue Damage
4
4
Unspecified Infection
3
3
Extravasation
3
3
Bacterial Infection
3
3
Urinary Retention
2
2
Vomiting
2
2
Nausea
2
2
Internal Organ Perforation
2
2
Unspecified Tissue Injury
2
2
Confusion/ Disorientation
2
2
Rupture
2
2
Nonresorbable materials, unretrieved in body
2
2
Discomfort
2
2
Complaint, Ill-Defined
1
1
Anxiety
1
1
Choking
1
1
Respiratory Failure
1
1
Sleep Dysfunction
1
1
Abdominal Cramps
1
1
Ambulation Difficulties
1
1
Fungal Infection
1
1
Abdominal Distention
1
1
Bowel Perforation
1
1
Tissue Breakdown
1
1
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available
1
1
Patient Problem/Medical Problem
1
1
Constipation
1
1
Unspecified Mental, Emotional or Behavioural Problem
1
1
Unspecified Immune System Problem
1
1
Unspecified Respiratory Problem
1
1
Gastrointestinal Hemorrhage
1
1
Pancreatitis
1
1
Localized Skin Lesion
1
1
Pneumonia
1
1
Septic Shock
1
1
Burning Sensation
1
1
Unknown (for use when the patient's condition is not known)
1
1
Abnormal Vaginal Discharge
1
1
Erosion
1
1
Stroke/CVA
1
1
Death
1
1
Diarrhea
1
1
Edema
1
1
Emotional Changes
1
1
Abdominal Pain
1
1
Abscess
1
1
Anaphylactic Shock
1
1
Autoimmune Disorder
1
1
Fatigue
1
1
Fever
1
1
Fistula
1
1
Headache
1
1
Myocardial Infarction
1
1
Recalls
Manufacturer
Recall Class
Date Posted
1
C.R. Bard, Inc.
II
Oct-31-2014
2
Philips North America, LLC
II
Apr-13-2022
3
Sterilmed Inc
II
Jan-13-2009
4
Wilson-Cook Medical Inc.
II
Jul-28-2023
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