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nezhat-dorsey bipolar electrosurgical forceps surface electrodes and cords
American Hydro-Surgical Instruments
Summary: The Nezhat-Dorsey Bipolar Electrosurgical Forceps are used for tissue ablation and coagulation. Primarily utilized in tumor ablation procedures, key evidence highlights its effectiveness in reducing hemorrhage compared to cold dissection.
FDA Clearance Information
Pathway
510K
Number
K945694 ↗
Decision Date
February 17, 1995
Product Code
GEI
Device Class
Class 2
Evidence
0 studies
The device was cleared by the FDA through the 510(k) pathway on February 17, 1995. Manufactured by American Hydro-Surgical Instruments, it is classified as a Class 2 medical device.
What It Is
The Nezhat-Dorsey Bipolar Electrosurgical Forceps are designed for electrosurgical procedures, providing precise tissue coagulation and ablation. It is intended for use in surgical settings requiring controlled thermal energy application.
Clinical Applications
Commonly used in laparoscopic surgeries, particularly for tumor ablation and tissue coagulation. It is often employed in procedures where minimizing blood loss is critical, such as hepatic resections and gynecological surgeries.
Evidence Summary
The literature includes various study types such as RCTs and case series, with a total of 6 studies spanning from 2008 to 2018. These studies explore the device's efficacy and safety in different surgical contexts.
Reported Outcomes
Published studies report that the Nezhat-Dorsey Bipolar Electrosurgical Forceps effectively reduce hemorrhage compared to traditional methods. The device is noted for its ability to achieve hemostasis in challenging surgical environments, such as laparoscopic renal and hepatic surgeries.
Safety Profile
Reported complications include potential thermal damage to surrounding tissues, as highlighted in studies comparing different electrosurgical instruments. Careful application is advised to minimize unintended tissue effects.
Evidence Limitations
The evidence is limited by the small number of studies and the variability in study design. Further research is needed to establish long-term outcomes and to compare its efficacy directly with other electrosurgical devices.
Frequently Asked Questions
What are the clinical indications for Nezhat-Dorsey Bipolar Electrosurgical Forceps?
The device is indicated for tissue ablation and coagulation in surgical procedures, particularly in tumor ablation and laparoscopic surgeries.
What outcomes have been reported in clinical studies?
Studies report effective hemorrhage control and hemostasis in laparoscopic surgeries, with reduced bleeding compared to cold dissection techniques.
What complications have been reported?
Safety data indicate potential thermal damage to adjacent tissues, necessitating careful use to avoid unintended effects.
Disclaimer: This page compiles publicly available regulatory and published clinical evidence for educational reference.
It does not constitute medical advice, product endorsement, or a recommendation for clinical use.
Always consult manufacturer documentation and clinical judgment for patient care decisions.