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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
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


Premarket Reviews
ManufacturerDecision
RENOVO, INC.
  SUBSTANTIALLY EQUIVALENT 2
STRYKER SUSTAINABILITY SOLUTIONS
  SUBSTANTIALLY EQUIVALENT 1
SURGICAL INSTRUMENT SERVICE AND SAVINGS INC
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2017 15 15
2018 9 9
2019 6 6
2020 1 1
2021 5 5
2022 5 5

Device Problems MDRs with this Device Problem Events in those MDRs
Break 23 23
Detachment of Device or Device Component 6 6
Problem with Sterilization 4 4
Device Contamination with Chemical or Other Material 3 3
Gas/Air Leak 2 2
Fracture 2 2
Leak/Splash 2 2
Nonstandard Device 1 1
Delivered as Unsterile Product 1 1
Device Slipped 1 1
Failure to Cut 1 1
Detachment Of Device Component 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Consequences Or Impact To Patient 16 16
No Known Impact Or Consequence To Patient 10 10
Foreign Body In Patient 5 5
No Clinical Signs, Symptoms or Conditions 4 4
No Information 3 3
Insufficient Information 3 3
Nausea 1 1
Pain 1 1
Vomiting 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Stryker Sustainability Solutions II Nov-27-2018
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