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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
1. K190492
Peralta Stone Removal Catheter
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
Adverse Event Without Identified Device or Use Problem
97
97
Fracture
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
Loose or Intermittent Connection
12
12
Device Inoperable
12
12
Mechanical Jam
12
12
Component Missing
11
11
Use of Device Problem
10
10
Device Operational Issue
10
10
Device Packaging Compromised
10
10
Kinked
10
10
Nonstandard Device
10
10
Physical Resistance/Sticking
10
10
Appropriate Term/Code Not Available
10
10
Bent
9
9
Entrapment of Device
9
9
Contamination /Decontamination Problem
9
9
Off-Label Use
8
8
Disconnection
8
8
Material Frayed
8
8
Torn Material
8
8
Improper or Incorrect Procedure or Method
7
7
Retraction Problem
7
7
Unintended Collision
6
6
Material Rupture
5
5
Packaging Problem
5
5
Difficult to Advance
5
5
Insufficient Information
4
4
Solder Joint Fracture
4
4
Structural Problem
4
4
Component Falling
4
4
Accessory Incompatible
3
3
Migration or Expulsion of Device
3
3
Peeled/Delaminated
3
3
Device Or Device Fragments Location Unknown
3
3
Activation, Positioning or Separation Problem
3
3
Sticking
3
3
Sharp Edges
3
3
Component Misassembled
3
3
Device Dislodged or Dislocated
3
3
Material Protrusion/Extrusion
2
2
Separation Problem
2
2
Therapeutic or Diagnostic Output Failure
2
2
Device Handling Problem
2
2
Stretched
2
2
Unraveled Material
2
2
Out-Of-Box Failure
2
2
Device-Device Incompatibility
2
2
Connection Problem
2
2
Failure to Advance
2
2
Split
2
2
Separation Failure
2
2
Misassembled
2
2
Difficult to Insert
2
2
Component(s), broken
2
2
Failure to Capture
1
1
Coiled
1
1
Collapse
1
1
Contamination
1
1
Crack
1
1
Degraded
1
1
Flaked
1
1
Positioning Failure
1
1
Material Discolored
1
1
Incorrect Measurement
1
1
Product Quality Problem
1
1
Device Damaged by Another Device
1
1
Device Disinfection Or Sterilization Issue
1
1
Device Markings/Labelling Problem
1
1
Wire(s), breakage of
1
1
Defective Component
1
1
Microbial Contamination of Device
1
1
Failure to Unfold or Unwrap
1
1
Device Slipped
1
1
Migration
1
1
Device Fell
1
1
Activation Problem
1
1
Material Too Soft/Flexible
1
1
Material Integrity Problem
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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