Normal use
Instructions for use • Articulating Needle Holder • FIP643_EN_V1.0_02-2021_IFU_CE-MDR
5
2 Normal use
2.1 Intended use
Sheaths
Sheaths are used for guidance in a trocar of a take-apart instrument to create sutures and
ligatures in:
–
Operative laparoscopy
–
Gynecology
–
Urology
–
Operative thoracoscopy
–
Transanal interventions
Sheaths are designed for transient use in surgically invasive interventions.
Handle
Handles are used for opening and closing the jaw of a take-apart instrument to create sutures
and ligatures in:
–
Operative laparoscopy
–
Gynecology
–
Urology
–
Operative thoracoscopy
–
Transanal interventions
Handles are designed for transient use in surgical invasive interventions.
Working insert
Needle holder inserts are used in combination with the handle and outer sheath or inner sheath
if necessary of a take-apart instrument to create endoscopic sutures in:
–
Operative laparoscopy
–
Gynecology
–
Urology
–
Operative thoracoscopy
–
Transanal interventions
Needle holder inserts are designed for transient use in surgically invasive interventions.
2.2 Indications
The products in this clinical evaluation are used in:
–
Laparoscopic surgery
–
Gynecology
–
Urology
–
Thyroid surgery (extracervical access)
–
Thoracic surgery
–
Diagnostic and operative thoracoscopy
–
NOTES
–
Transanal interventions
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