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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
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
2019 59 59
2020 40 40
2021 26 26
2022 38 38
2023 54 54
2024 42 42

Device Problems MDRs with this Device Problem Events in those MDRs
Difficult to Open or Close 69 69
Failure to Align 30 30
Break 29 29
Detachment of Device or Device Component 17 17
Difficult to Remove 16 16
Difficult to Open or Remove Packaging Material 13 13
Failure to Cut 13 13
Fracture 12 12
Packaging Problem 12 12
Nonstandard Device 11 11
Device Reprocessing Problem 10 10
Appropriate Term/Code Not Available 10 10
Material Twisted/Bent 10 10
Entrapment of Device 8 8
Mechanical Problem 8 8
Tear, Rip or Hole in Device Packaging 8 8
Dull, Blunt 7 7
Failure to Clean Adequately 7 7
Component Misassembled 7 7
Contamination 6 6
Adverse Event Without Identified Device or Use Problem 6 6
Device Handling Problem 5 5
Material Split, Cut or Torn 4 4
Deformation Due to Compressive Stress 3 3
Physical Resistance/Sticking 3 3
Corroded 2 2
Material Protrusion/Extrusion 2 2
Device Damaged by Another Device 2 2
Use of Device Problem 2 2
Difficult to Advance 2 2
Solder Joint Fracture 1 1
Problem with Sterilization 1 1
Thermal Decomposition of Device 1 1
Component Missing 1 1
No Apparent Adverse Event 1 1
Material Fragmentation 1 1
Device Dislodged or Dislocated 1 1
Insufficient Information 1 1
Separation Failure 1 1
Non Reproducible Results 1 1
Peeled/Delaminated 1 1
Improper or Incorrect Procedure or Method 1 1
Off-Label Use 1 1
Mechanical Jam 1 1
Migration or Expulsion of Device 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 147 147
No Consequences Or Impact To Patient 63 63
No Patient Involvement 17 17
Foreign Body In Patient 8 8
Hemostasis 8 8
Tissue Damage 6 6
No Known Impact Or Consequence To Patient 5 5
Hemorrhage/Bleeding 4 4
No Code Available 3 3
Insufficient Information 3 3
Gastrointestinal Hemorrhage 2 2
Hematoma 2 2
Device Embedded In Tissue or Plaque 2 2
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 1 1
Pancreatitis 1 1
Inflammation 1 1
Perforation 1 1
Edema 1 1
Laceration(s) of Esophagus 1 1
Injury 1 1
Laceration(s) 1 1
Unspecified Hepatic or Biliary Problem 1 1

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