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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, exempt
Regulation Description Endoscope and accessories.
Definition This product code is the class II exempt counterpart of OCZ, and was exempted, subject to the limitations of exemption, under the procedures established by the 21st Century Cures Act. This device type does not require premarket notification (510(k)) to market if it does not exceed the general limitations of exemption found in 21 CFR 876.9 and the specific limitations of exemption as stated in the “Physical State” field of this product code description.
Product CodePTS
Regulation Number 876.1500
Device Class 2

MDR Year MDR Reports MDR Events
2021 26 26
2022 38 38
2023 54 54
2024 42 42
2025 33 33
2026 20 20

Device Problems MDRs with this Device Problem Events in those MDRs
Difficult to Open or Close 63 63
Break 25 25
Detachment of Device or Device Component 16 16
Device Reprocessing Problem 14 14
Difficult to Open or Remove Packaging Material 13 13
Packaging Problem 12 12
Material Twisted/Bent 12 12
Fracture 11 11
Nonstandard Device 11 11
Difficult to Remove 10 10
Failure to Cut 10 10
Tear, Rip or Hole in Device Packaging 10 10
Mechanical Problem 9 9
Failure to Clean Adequately 7 7
Adverse Event Without Identified Device or Use Problem 6 6
Mechanical Jam 6 6
Entrapment of Device 6 6
Contamination 6 6
Component Misassembled 5 5
Material Split, Cut or Torn 4 4
Deformation Due to Compressive Stress 3 3
Insufficient Device Problem Information 3 3
Appropriate Device Problem Term/Code Not Available 3 3
Use of Device Problem 2 2
Difficult to Advance 2 2
Corroded 2 2
No Apparent Adverse Event 2 2
Component Missing 1 1
Problem with Sterilization 1 1
Contamination /Decontamination Problem 1 1
Material Separation 1 1
Device Damaged by Another Device 1 1
Off-Label Use 1 1
Delivered as Unsterile Product 1 1
Device Dislodged or Dislocated 1 1
Material Deformation 1 1
Material Protrusion/Extrusion 1 1
Material Fragmentation 1 1
Device Handling Problem 1 1
Physical Resistance/Sticking 1 1
Non Reproducible Results 1 1
Difficult or Delayed Separation 1 1
Thermal Decomposition of Device 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 190 190
Hemorrhage/Blood Loss/Bleeding 6 6
Foreign Body In Patient 6 6
Gastrointestinal Hemorrhage 4 4
Insufficient Information 3 3
Laceration(s) 1 1
Pancreatitis 1 1
Inflammation 1 1
Perforation 1 1
Ulcer 1 1
Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available 1 1
Unspecified Hepatic or Biliary Problem 1 1
Fibrosis 1 1
Unspecified Tissue Injury 1 1
No Code Available 1 1

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