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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

MDR Year MDR Reports MDR Events
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 26 26
Break 7 7
Mechanical Problem 6 6
Detachment of Device or Device Component 5 5
Obstruction of Flow 4 4
Suction Failure 4 4
Material Integrity Problem 3 3
Product Quality Problem 3 3
Complete Blockage 3 3
Material Twisted/Bent 2 2
Communication or Transmission Problem 2 2
Fracture 2 2
Key or Button Unresponsive/not Working 1 1
Optical Problem 1 1
Temperature Problem 1 1
Appropriate Term/Code Not Available 1 1
Physical Resistance/Sticking 1 1
Excessive Heating 1 1
Deflation Problem 1 1
Erratic or Intermittent Display 1 1
Display or Visual Feedback Problem 1 1
Melted 1 1
Misfocusing 1 1
Poor Quality Image 1 1
Overheating of Device 1 1
Device Difficult to Setup or Prepare 1 1
Material Separation 1 1
Suction Problem 1 1
Solder Joint Fracture 1 1
Device-Device Incompatibility 1 1
Difficult to Open or Close 1 1
Failure to Shut Off 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 20 20
Intracranial Hemorrhage 10 10
No Consequences Or Impact To Patient 10 10
Insufficient Information 9 9
Hemorrhage/Bleeding 6 6
Foreign Body In Patient 4 4
No Known Impact Or Consequence To Patient 4 4
Convulsion/Seizure 3 3
Hydrocephalus 2 2
Device Embedded In Tissue or Plaque 2 2
Brain Injury 2 2
Hematoma 2 2
Death 1 1
Headache 1 1
Patient Problem/Medical Problem 1 1
Hemorrhage, Intraventricular 1 1
Hemorrhage, Subarachnoid 1 1
Hemorrhage, Subdural 1 1
Inflammation 1 1
Respiratory Distress 1 1
Seizures 1 1
Tissue Damage 1 1
No Code Available 1 1
Full thickness (Third Degree) Burn 1 1
Cerebral Edema 1 1
Hemorrhagic Stroke 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 Sep-06-2023
2 Karl Storz Endoscopy II Mar-20-2020
3 Karl Storz Endoscopy II Aug-28-2019
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