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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device endoscopic guidewire, gastroenterology-urology
Definition To provide access to gi or gu tract for the purpose of passing or exchanging other accessories.
Product CodeOCY
Regulation Number 876.1500
Device Class 2


Premarket Reviews
ManufacturerDecision
BOSTON SCIENTIFIC CORP.
  SUBSTANTIALLY EQUIVALENT 1
COLOPLAST A/S
  SUBSTANTIALLY EQUIVALENT 2
LAKE REGION MEDICAL
  SUBSTANTIALLY EQUIVALENT 3
MEDI-GLOBE CORPORATION
  SUBSTANTIALLY EQUIVALENT 1
NEOMETRICS, INC.
  SUBSTANTIALLY EQUIVALENT 3
TERUMO CORP.
  SUBSTANTIALLY EQUIVALENT 1
TERUMO MEDICAL CORPORATION
  SUBSTANTIALLY EQUIVALENT 1
WILSON-COOK MEDICAL INC.
  SUBSTANTIALLY EQUIVALENT 1
WILSON-COOK MEDICAL, INC
  SUBSTANTIALLY EQUIVALENT 1
XENOLITH MEDICAL
  SUBSTANTIALLY EQUIVALENT 2

MDR Year MDR Reports MDR Events
2014 51 51
2015 283 283
2016 158 158
2017 85 85
2018 101 101
2019 102 102
2020 128 128
2021 94 94
2022 134 134
2023 115 115
2024 30 30

Device Problems MDRs with this Device Problem Events in those MDRs
Peeled/Delaminated 411 411
Detachment Of Device Component 378 378
Material Separation 112 112
Break 104 104
Adverse Event Without Identified Device or Use Problem 62 62
Detachment of Device or Device Component 31 31
Fracture 27 27
Positioning Problem 23 23
Migration or Expulsion of Device 20 20
Material Fragmentation 19 19
Material Twisted/Bent 19 19
Material Deformation 18 18
Unraveled Material 17 17
Improper or Incorrect Procedure or Method 11 11
Difficult to Advance 11 11
Deformation Due to Compressive Stress 10 10
Entrapment of Device 10 10
Flaked 9 9
Device Damaged by Another Device 9 9
Appropriate Term/Code Not Available 9 9
Insufficient Information 8 8
Off-Label Use 8 8
Difficult to Remove 7 7
Device Damaged Prior to Use 7 7
Positioning Failure 7 7
Material Frayed 7 7
Use of Device Problem 6 6
Material Integrity Problem 6 6
Defective Device 5 5
Physical Resistance/Sticking 5 5
Material Too Rigid or Stiff 5 5
Unsealed Device Packaging 5 5
Bent 5 5
Material Disintegration 4 4
Difficult to Insert 4 4
Microbial Contamination of Device 4 4
Device-Device Incompatibility 4 4
Device Operates Differently Than Expected 4 4
Device Dislodged or Dislocated 4 4
Device Contamination with Chemical or Other Material 4 4
Device Contaminated During Manufacture or Shipping 4 4
Material Protrusion/Extrusion 3 3
Contamination /Decontamination Problem 3 3
Failure to Advance 2 2
No Apparent Adverse Event 2 2
Mechanical Jam 2 2
Scratched Material 2 2
Migration 2 2
Material Split, Cut or Torn 2 2
Cut In Material 2 2
Particulates 2 2
Accessory Incompatible 2 2
Component Falling 1 1
Crack 1 1
Loose or Intermittent Connection 1 1
Delivered as Unsterile Product 1 1
Image Display Error/Artifact 1 1
Product Quality Problem 1 1
Uncoiled 1 1
Structural Problem 1 1
Component Missing 1 1
Wire(s), breakage of 1 1
Tear, Rip or Hole in Device Packaging 1 1
Inadequate Lubrication 1 1
Torn Material 1 1
Physical Resistance 1 1
Device Packaging Compromised 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Consequences Or Impact To Patient 687 687
No Clinical Signs, Symptoms or Conditions 297 297
No Known Impact Or Consequence To Patient 100 100
Foreign Body In Patient 73 73
Device Embedded In Tissue or Plaque 31 31
No Patient Involvement 28 28
Perforation 24 24
Insufficient Information 19 19
No Code Available 16 16
Swelling/ Edema 12 12
Pancreatitis 11 11
Hemorrhage/Bleeding 9 9
Pain 8 8
Internal Organ Perforation 5 5
Inflammation 5 5
Tingling 4 4
Bacterial Infection 4 4
No Information 4 4
Discomfort 4 4
Laceration(s) of Esophagus 4 4
Foreign body, removal of 3 3
Twitching 3 3
Sepsis 2 2
Laceration(s) 2 2
Hemostasis 2 2
Fever 2 2
Perforation of Esophagus 2 2
Blood Loss 2 2
Bowel Perforation 1 1
Gastrointestinal Hemorrhage 1 1
Respiratory Failure 1 1
Hematuria 1 1
Surgical procedure, additional 1 1
Peritonitis 1 1
Nonresorbable materials, unretrieved in body 1 1
Fistula 1 1
Unspecified Infection 1 1
Biliary Cirrhosis 1 1
Death 1 1
Abdominal Pain 1 1
Abrasion 1 1
Air Embolism 1 1
Septic Shock 1 1
Dysphasia 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Cook Inc. II Feb-04-2020
2 Cook Incorporated II Sep-28-2022
3 NEO METRICS, INC. II Jun-10-2014
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