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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device laparoscope, general & plastic surgery, reprocessed
Regulation Description Endoscope and accessories.
Definition The "Endoscope and accessories, reprocessed" is intended to provide access, illumination, and allow observation or manipulation of body cavities, hollow organs, and canals. This device is indicated for reuse/reprocessing. Reprocessing validation data for this device type must be included in a 510(k) submission. (70 FR 56911, available at https://www.govinfo.gov/content/pkg/FR-2005-09-29/pdf/05-19510.pdf).
Product CodeNLM
Regulation Number 876.1500
Device Class 2

MDR Year MDR Reports MDR Events
2021 5 5
2022 5 5
2023 5 5
2024 4 4
2025 11 11

Device Problems MDRs with this Device Problem Events in those MDRs
Fracture 8 8
Break 6 6
Use of Device Problem 4 4
Problem with Sterilization 4 4
Material Separation 4 4
Gas/Air Leak 2 2
Detachment of Device or Device Component 2 2
Physical Resistance/Sticking 1 1
Crack 1 1
Material Integrity Problem 1 1
Difficult to Remove 1 1
Degraded 1 1
Device Dislodged or Dislocated 1 1
Nonstandard Device 1 1
Difficult to Open or Close 1 1
Deformation Due to Compressive Stress 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 18 18
Foreign Body In Patient 7 7
Insufficient Information 5 5
Nausea 1 1
Vomiting 1 1
Pain 1 1

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