VCARE

Description of Event or Problem

A sales representative reported on behalf of a customer that the devic, 60-6085-201A, MEDIUM, UTERINE MANIPULATOR, was used in a Robotic Assisted Total Laparoscopic Hysterectomy, Bilateral Salpingectomy, Cystoscopy procedure on (b)(6) 2026, and experienced ¿screw failures on the device." Further assessment found "Assisted on a robotic hysterectomy and the Vcare uterine manipulator ¿malfunctioned¿ - the part of the manipulator that locks down the cup has failed in at least 2 cases and was told by the OR techs there have been similar issues with the device in other surgeries. The white screw loosens and the manipulator advanced and led to uterine perforation and can only be ratcheted down tightly with an instrument." There was no report of medical/surgical intervention, or extended hospitalization for the patient.This report is being raised due to the reported injury of uterine perforation.

Additional Manufacturer Narrative

G3 initial awareness date was (b)(6) 2026.The device is not expected to be returned for evaluation and review. However, the complaint investigation is not complete at this time. A supplemental and final report will be filed following the completion of the complaint investigation.We will continue to monitor per regulatory requirements to help ensure patient safety.