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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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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
AESCULAP, INC.
  SUBSTANTIALLY EQUIVALENT 1
CARL ZEISS MEDITEC AG
  SUBSTANTIALLY EQUIVALENT 3
CLARUS MEDICAL, LLC
  SUBSTANTIALLY EQUIVALENT 2
CLEARMIND BIOMEDICAL
  SUBSTANTIALLY EQUIVALENT 3
HJY SMART MEDICAL DEVICE CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
KARL STORZ ENDOSCOPY AMERICA, INC
  SUBSTANTIALLY EQUIVALENT 1
KARL STORZ ENDOSCOPY AMERICA, INC.
  SUBSTANTIALLY EQUIVALENT 1
KARL STORZ ENDOSCOPY-AMERICA, INC.
  SUBSTANTIALLY EQUIVALENT 2
MAUNA KEA TECHNOLOGIES
  SUBSTANTIALLY EQUIVALENT 1
MRI INTERVENTIONS, INC.
  SUBSTANTIALLY EQUIVALENT 1
PENUMBRA, INC.
  SUBSTANTIALLY EQUIVALENT 4
REBOUND THERAPEUTICS
  SUBSTANTIALLY EQUIVALENT 2
REBOUND THERAPEUTICS CORPORATION
  SUBSTANTIALLY EQUIVALENT 2
STRYKER
  SUBSTANTIALLY EQUIVALENT 1
VISIONSENSE, LTD.
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2014 19 19
2015 37 37
2016 25 25
2017 12 12
2018 16 16
2019 10 10
2020 19 19
2021 21 21
2022 12 12
2023 9 9
2024 3 3

Device Problems MDRs with this Device Problem Events in those MDRs
Adverse Event Without Identified Device or Use Problem 41 41
Break 17 17
Leak/Splash 17 17
Device Operates Differently Than Expected 14 14
Complete Blockage 12 12
Mechanical Problem 11 11
Aspiration Issue 7 7
Detachment of Device or Device Component 7 7
Device Operational Issue 5 5
Out-Of-Box Failure 5 5
Poor Quality Image 5 5
Obstruction of Flow 4 4
Material Integrity Problem 4 4
Suction Failure 4 4
Appropriate Term/Code Not Available 3 3
Material Protrusion/Extrusion 3 3
Defective Device 3 3
Product Quality Problem 3 3
Fluid/Blood Leak 3 3
Fracture 3 3
Burst Container or Vessel 3 3
Bent 2 2
Failure to Conduct 2 2
Material Fragmentation 2 2
Image Resolution Poor 2 2
Detachment Of Device Component 2 2
Display or Visual Feedback Problem 2 2
Difficult to Remove 2 2
Material Separation 2 2
Overheating of Device 2 2
Solder Joint Fracture 2 2
Device Difficult to Setup or Prepare 2 2
Vibration 2 2
Device Damaged Prior to Use 2 2
Material Twisted/Bent 2 2
Communication or Transmission Problem 2 2
Pumping Problem 2 2
Temperature Problem 1 1
Key or Button Unresponsive/not Working 1 1
Device Handling Problem 1 1
Physical Resistance/Sticking 1 1
Excessive Heating 1 1
Device Misassembled During Manufacturing /Shipping 1 1
Optical Problem 1 1
Device-Device Incompatibility 1 1
Difficult to Open or Close 1 1
Device Dislodged or Dislocated 1 1
Failure to Shut Off 1 1
Inadequate User Interface 1 1
Material Deformation 1 1
Arcing of Electrodes 1 1
Defective Component 1 1
Component Missing 1 1
Suction Problem 1 1
Material Puncture/Hole 1 1
Device Or Device Fragments Location Unknown 1 1
Failure to Disconnect 1 1
Difficult or Delayed Activation 1 1
Date/Time-Related Software Problem 1 1
Loss of Power 1 1
Occlusion Within Device 1 1
Melted 1 1
Misfocusing 1 1
Device Slipped 1 1
Device Inoperable 1 1
Use of Device Problem 1 1
Material Rupture 1 1
Self-Activation or Keying 1 1
Failure to Deliver Energy 1 1
False Positive Result 1 1
Component Falling 1 1
Kinked 1 1
Decrease in Suction 1 1
Deflation Problem 1 1
Disconnection 1 1
Material Disintegration 1 1
Erratic or Intermittent Display 1 1
Loss of or Failure to Bond 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Consequences Or Impact To Patient 46 46
No Known Impact Or Consequence To Patient 46 46
No Clinical Signs, Symptoms or Conditions 20 20
No Patient Involvement 11 11
No Code Available 10 10
Intracranial Hemorrhage 10 10
Insufficient Information 9 9
Hemorrhage/Bleeding 7 7
Foreign Body In Patient 5 5
Brain Injury 3 3
Hydrocephalus 3 3
Convulsion/Seizure 3 3
Device Embedded In Tissue or Plaque 3 3
Unspecified Infection 2 2
Death 2 2
Hemorrhage, Intraventricular 2 2
Seizures 2 2
Hematoma 2 2
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 1 1
Seroma 1 1
Therapeutic Effects, Unexpected 1 1
Tissue Damage 1 1
Hemorrhage, Subarachnoid 1 1
Hemorrhage, Subdural 1 1
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
Inflammation 1 1
Respiratory Distress 1 1
Patient Problem/Medical Problem 1 1
Therapeutic Response, Decreased 1 1
Meningitis 1 1
No Information 1 1
Full thickness (Third Degree) Burn 1 1
Hemorrhagic Stroke 1 1
Ischemia Stroke 1 1
Cerebral Edema 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Aesculap Implant Systems LLC II Sep-06-2023
2 Aesculap Implant Systems LLC II Mar-20-2017
3 Geomed Medizin-Technik Gmbh & Co. II Feb-19-2012
4 Karl Storz Endoscopy II Mar-20-2020
5 Karl Storz Endoscopy II Aug-28-2019
6 Mitaka USA, Inc. II May-11-2012
7 Visionsense, Ltd. II Mar-08-2012
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