MalfunctionLKF

UTERINE MANIPULATOR

Received May 31, 2024 · Event occurred May 28, 2024

Report MW5155678 · MDR key 19449127

Device

Generic name

Cannula, Manipulator/injector, Uterine

Manufacturer

Bioteque America, Inc.

Model number

UMI4.5K

Lot number

A221004

Patient

NA · Unknown

No Clinical Signs, Symptoms or Conditions
No Clinical Signs, Symptoms or Conditions

Narrative

Description of Event or Problem

THE TEAM HAS REPORTED THAT THE UTERINE MANIPULATORS FROM BIOTEQUE AMERICA HAVE BEEN MALFUNCTIONING. THE BALLOON AT THE END WILL NOT DEFLATE. I DO NOT HAVE ANY SPECIFIC PATIENTS THIS HAPPENED ON, A TECH BROUGHT IT TO MY ATTENTION AND GAVE ME ONE THAT HAD BEEN OPENED BUT NOT USED. BIOTEQUE AMERICA, SKU#: UMI4.5K, LOT: A221004, EXP: 2025-09-30.