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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Super Search Devices@FDA
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Device endoscope, neurological
Definition If the device is reusable, validated reprocessing instructions and reprocessing validation data for this device type must be included in a 510(k) submission (82 FR 26807, available at https://www.gpo.gov/fdsys/pkg/FR-2017-06-09/pdf/2017-12007.pdf).
Product CodeGWG
Regulation Number 882.1480
Device Class 2


Premarket Reviews
ManufacturerDecision
CARL ZEISS MEDITEC AG
  SUBSTANTIALLY EQUIVALENT 2
CLARUS MEDICAL, LLC
  SUBSTANTIALLY EQUIVALENT 1
CLEARMIND BIOMEDICAL
  SUBSTANTIALLY EQUIVALENT 2
KARL STORZ ENDOSCOPY AMERICA, INC
  SUBSTANTIALLY EQUIVALENT 1
KARL STORZ ENDOSCOPY AMERICA, INC.
  SUBSTANTIALLY EQUIVALENT 1
KARL STORZ ENDOSCOPY-AMERICA, INC.
  SUBSTANTIALLY EQUIVALENT 1
MAUNA KEA TECHNOLOGIES
  SUBSTANTIALLY EQUIVALENT 1
MRI INTERVENTIONS, INC.
  SUBSTANTIALLY EQUIVALENT 1
PENUMBRA, INC.
  SUBSTANTIALLY EQUIVALENT 2
REBOUND THERAPEUTICS
  SUBSTANTIALLY EQUIVALENT 2
REBOUND THERAPEUTICS CORPORATION
  SUBSTANTIALLY EQUIVALENT 1
STRYKER
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2017 12 12
2018 16 16
2019 10 10
2020 19 19
2021 21 21
2022 11 11

Device Problems MDRs with this Device Problem Events in those MDRs
Adverse Event Without Identified Device or Use Problem 27 27
Break 10 10
Mechanical Problem 10 10
Device Operates Differently Than Expected 5 5
Obstruction of Flow 4 4
Suction Failure 4 4
Detachment of Device or Device Component 4 4
Complete Blockage 4 4
Poor Quality Image 3 3
Product Quality Problem 3 3
Material Integrity Problem 3 3
Material Twisted/Bent 2 2
Defective Device 2 2
Leak/Splash 2 2
Communication or Transmission Problem 2 2
Appropriate Term/Code Not Available 2 2
Overheating of Device 2 2
Material Separation 2 2
Out-Of-Box Failure 2 2
Display or Visual Feedback Problem 2 2
Fracture 2 2
Material Fragmentation 1 1
Melted 1 1
Misfocusing 1 1
Detachment Of Device Component 1 1
Decrease in Suction 1 1
Deflation Problem 1 1
Solder Joint Fracture 1 1
Suction Problem 1 1
Arcing of Electrodes 1 1
Device Difficult to Setup or Prepare 1 1
Material Rupture 1 1
Physical Resistance/Sticking 1 1
Optical Problem 1 1
Temperature Problem 1 1
Key or Button Unresponsive/not Working 1 1
Aspiration Issue 1 1
Device-Device Incompatibility 1 1
Failure to Shut Off 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Consequences Or Impact To Patient 19 19
No Clinical Signs, Symptoms or Conditions 17 17
No Known Impact Or Consequence To Patient 9 9
Hemorrhage/Bleeding 7 7
Insufficient Information 6 6
Foreign Body In Patient 5 5
Intracranial Hemorrhage 5 5
No Patient Involvement 4 4
Brain Injury 3 3
Hydrocephalus 3 3
Device Embedded In Tissue or Plaque 2 2
No Code Available 2 2
Hematoma 2 2
Seizures 2 2
Death 2 2
Edema 1 1
Fever 1 1
Headache 1 1
Hemorrhage, Cerebral 1 1
Abscess 1 1
Bacterial Infection 1 1
Cerebrospinal Fluid Leakage 1 1
Seroma 1 1
Therapeutic Effects, Unexpected 1 1
Tissue Damage 1 1
Hemorrhage, Intraventricular 1 1
Hemorrhage, Subarachnoid 1 1
Hemorrhage, Subdural 1 1
Unspecified Infection 1 1
Inflammation 1 1
Respiratory Distress 1 1
Meningitis 1 1
Patient Problem/Medical Problem 1 1
Full thickness (Third Degree) Burn 1 1
Convulsion/Seizure 1 1
Ischemia Stroke 1 1
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Aesculap Implant Systems LLC II Mar-20-2017
2 Karl Storz Endoscopy II Mar-20-2020
3 Karl Storz Endoscopy II Aug-28-2019
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