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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
CARL ZEISS MEDITEC AG
  SUBSTANTIALLY EQUIVALENT 1
CLARUS MEDICAL, LLC
  SUBSTANTIALLY EQUIVALENT 2
CLEARMIND BIOMEDICAL
  SUBSTANTIALLY EQUIVALENT 3
HJY SMART MEDICAL DEVICE CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
PENUMBRA, INC.
  SUBSTANTIALLY EQUIVALENT 1
REBOUND THERAPEUTICS
  SUBSTANTIALLY EQUIVALENT 2
REBOUND THERAPEUTICS CORPORATION
  SUBSTANTIALLY EQUIVALENT 2
STRYKER
  SUBSTANTIALLY EQUIVALENT 1
VPIX MEDICAL, INC.
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2019 10 10
2020 19 19
2021 21 21
2022 12 12
2023 9 9
2024 9 9

Device Problems MDRs with this Device Problem Events in those MDRs
Adverse Event Without Identified Device or Use Problem 26 26
Break 7 7
Detachment of Device or Device Component 7 7
Mechanical Problem 6 6
Suction Failure 4 4
Obstruction of Flow 4 4
Complete Blockage 3 3
Material Integrity Problem 3 3
Product Quality Problem 3 3
Communication or Transmission Problem 2 2
Poor Quality Image 2 2
Material Twisted/Bent 2 2
Solder Joint Fracture 2 2
Optical Problem 2 2
Material Separation 2 2
Fracture 2 2
Device-Device Incompatibility 1 1
Failure to Shut Off 1 1
No Display/Image 1 1
Physical Resistance/Sticking 1 1
Deflation Problem 1 1
Key or Button Unresponsive/not Working 1 1
Device Difficult to Setup or Prepare 1 1
Erratic or Intermittent Display 1 1
Appropriate Term/Code Not Available 1 1
Excessive Heating 1 1
Melted 1 1
Suction Problem 1 1
Overheating of Device 1 1
Difficult to Open or Close 1 1
Display or Visual Feedback Problem 1 1
Misfocusing 1 1
Temperature Problem 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 24 24
Intracranial Hemorrhage 10 10
Insufficient Information 10 10
No Consequences Or Impact To Patient 10 10
Hemorrhage/Bleeding 7 7
No Known Impact Or Consequence To Patient 4 4
Foreign Body In Patient 4 4
Convulsion/Seizure 3 3
Brain Injury 2 2
Hematoma 2 2
Hydrocephalus 2 2
Device Embedded In Tissue or Plaque 2 2
Patient Problem/Medical Problem 1 1
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 1 1
Death 1 1
Respiratory Distress 1 1
Seizures 1 1
No Code Available 1 1
Inflammation 1 1
Hemorrhagic Stroke 1 1
Hemorrhage, Subdural 1 1
Hemorrhage, Intraventricular 1 1
Tissue Damage 1 1
Headache 1 1
Hemorrhage, Subarachnoid 1 1
Full thickness (Third Degree) Burn 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 Integra LifeSciences Corp. II Jul-11-2024
3 Karl Storz Endoscopy II Mar-20-2020
4 Karl Storz Endoscopy II Aug-28-2019
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