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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
2017 5 5
2018 29 29
2019 59 59
2020 40 40
2021 26 26
2022 38 38
2023 54 54
2024 28 28

Device Problems MDRs with this Device Problem Events in those MDRs
Difficult to Open or Close 72 72
Failure to Align 36 36
Break 32 32
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
Packaging Problem 12 12
Dull, Blunt 11 11
Device Handling Problem 11 11
Mechanical Problem 10 10
Device Reprocessing Problem 10 10
Appropriate Term/Code Not Available 10 10
Material Twisted/Bent 10 10
Nonstandard Device 8 8
Fracture 8 8
Failure to Clean Adequately 7 7
Tear, Rip or Hole in Device Packaging 7 7
Adverse Event Without Identified Device or Use Problem 7 7
Component Misassembled 6 6
Contamination 6 6
Entrapment of Device 5 5
Material Split, Cut or Torn 4 4
Deformation Due to Compressive Stress 3 3
Corroded 2 2
Material Protrusion/Extrusion 2 2
Solder Joint Fracture 2 2
Device Damaged by Another Device 2 2
Use of Device Problem 2 2
Difficult to Advance 2 2
Peeled/Delaminated 2 2
Physical Resistance/Sticking 2 2
Problem with Sterilization 1 1
Thermal Decomposition of Device 1 1
Retraction Problem 1 1
Component Missing 1 1
Material Fragmentation 1 1
No Apparent Adverse Event 1 1
Material Integrity Problem 1 1
Insufficient Information 1 1
Device Dislodged or Dislocated 1 1
Separation Failure 1 1
Non Reproducible Results 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 134 134
No Consequences Or Impact To Patient 92 92
No Patient Involvement 18 18
Foreign Body In Patient 10 10
Hemostasis 9 9
Tissue Damage 9 9
No Known Impact Or Consequence To Patient 8 8
Hemorrhage/Bleeding 5 5
No Code Available 3 3
Gastrointestinal Hemorrhage 2 2
Hematoma 2 2
Insufficient Information 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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