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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 85 85

Device Problems MDRs with this Device Problem Events in those MDRs
Peeled/Delaminated 442 442
Detachment Of Device Component 378 378
Material Separation 124 124
Break 108 108
Adverse Event Without Identified Device or Use Problem 64 64
Detachment of Device or Device Component 31 31
Fracture 28 28
Positioning Problem 23 23
Material Fragmentation 22 22
Migration or Expulsion of Device 20 20
Material Twisted/Bent 19 19
Unraveled Material 19 19
Material Deformation 18 18
Difficult to Advance 12 12
Entrapment of Device 11 11
Improper or Incorrect Procedure or Method 11 11
Deformation Due to Compressive Stress 10 10
Device Damaged by Another Device 10 10
Flaked 9 9
Insufficient Information 9 9
Appropriate Term/Code Not Available 9 9
Device Damaged Prior to Use 8 8
Off-Label Use 8 8
Difficult to Remove 8 8
Material Frayed 7 7
Positioning Failure 7 7
Material Integrity Problem 6 6
Device Contaminated During Manufacture or Shipping 6 6
Use of Device Problem 6 6
Physical Resistance/Sticking 5 5
Unsealed Device Packaging 5 5
Defective Device 5 5
Material Too Rigid or Stiff 5 5
Bent 5 5
Device Operates Differently Than Expected 4 4
Device Dislodged or Dislocated 4 4
Material Disintegration 4 4
Microbial Contamination of Device 4 4
Device Contamination with Chemical or Other Material 4 4
Device-Device Incompatibility 4 4
Difficult to Insert 4 4
Accessory Incompatible 3 3
Material Split, Cut or Torn 3 3
Contamination /Decontamination Problem 3 3
Material Protrusion/Extrusion 3 3
Failure to Advance 2 2
Migration 2 2
No Apparent Adverse Event 2 2
Mechanical Jam 2 2
Scratched Material 2 2

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 341 341
No Known Impact Or Consequence To Patient 100 100
Foreign Body In Patient 77 77
Device Embedded In Tissue or Plaque 31 31
No Patient Involvement 28 28
Perforation 24 24
Insufficient Information 23 23
No Code Available 16 16
Swelling/ Edema 12 12
Hemorrhage/Bleeding 11 11
Pancreatitis 11 11
Pain 8 8
Internal Organ Perforation 6 6
Inflammation 5 5
No Information 4 4
Laceration(s) of Esophagus 4 4
Tingling 4 4
Discomfort 4 4
Bacterial Infection 4 4
Foreign body, removal of 3 3
Twitching 3 3
Gastrointestinal Hemorrhage 2 2
Sepsis 2 2
Perforation of Esophagus 2 2
Blood Loss 2 2
Fever 2 2
Hemostasis 2 2
Laceration(s) 2 2
Hematuria 1 1
Bowel Perforation 1 1
Abrasion 1 1
Death 1 1
Peritonitis 1 1
Retroperitoneal Hemorrhage 1 1
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 1 1
Septic Shock 1 1
Vomiting 1 1
Nonresorbable materials, unretrieved in body 1 1
Surgical procedure, additional 1 1
Biliary Cirrhosis 1 1
Dysphasia 1 1
Unspecified Infection 1 1
Air Embolism 1 1
Respiratory Failure 1 1
Fistula 1 1
Abdominal Pain 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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