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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device endoscopic grasping/cutting instrument, non-powered
Regulation Description Endoscope and accessories.
Definition To manually grasp stones, tissues or other objects through an endoscope. To manipulate, sample or cut tissues through an endoscope.
Product CodeOCZ
Regulation Number 876.1500
Device Class 2


Premarket Reviews
ManufacturerDecision
ENVISION ENDOSCOPY
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2021 20 20
2022 33 34
2023 25 25
2024 37 37
2025 34 34

Device Problems MDRs with this Device Problem Events in those MDRs
Break 48 48
Difficult to Open or Close 23 23
Detachment of Device or Device Component 13 13
Material Fragmentation 12 12
Mechanical Problem 8 8
Adverse Event Without Identified Device or Use Problem 8 8
Insufficient Information 7 7
Mechanical Jam 5 5
Material Separation 4 4
Arcing 4 4
Unintended Movement 3 3
Mechanics Altered 3 3
Flushing Problem 3 3
Improper or Incorrect Procedure or Method 3 3
Temperature Problem 3 3
Activation, Positioning or Separation Problem 2 2
Entrapment of Device 2 2
Physical Resistance/Sticking 2 2
Defective Device 2 3
Difficult to Remove 2 2
Use of Device Problem 2 2
Material Twisted/Bent 2 2
Failure to Cut 2 2
Unexpected Shutdown 1 1
Activation Problem 1 1
Device Fell 1 1
Unsealed Device Packaging 1 1
Electrical Overstress 1 1
Material Integrity Problem 1 1
Device Damaged by Another Device 1 1
Sharp Edges 1 1
Material Deformation 1 1
Packaging Problem 1 1
Device Handling Problem 1 1
Product Quality Problem 1 1
Activation Failure 1 1
Device Reprocessing Problem 1 1
Arcing of Electrodes 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 99 99
Insufficient Information 28 29
Foreign Body In Patient 13 13
Superficial (First Degree) Burn 4 4
Laceration(s) 4 4
Burn(s) 3 3
Hemorrhage/Bleeding 3 3
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 2 2
Perforation 2 2
Abdominal Pain 1 1
Patient Problem/Medical Problem 1 1
Bowel Perforation 1 1
Abdominal Distention 1 1
Pericardial Effusion 1 1
Blister 1 1
Pain 1 1
Partial thickness (Second Degree) Burn 1 1
Granuloma 1 1
Low Blood Pressure/ Hypotension 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Hobbs Medical, Inc. II Oct-07-2022
2 Hobbs Medical, Inc. II Jul-15-2022
3 Shent USA, Inc. II Aug-06-2021
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