inforMED
MalfunctionLWH

SITUATE DETECTION SYSTEM

Received Aug 9, 2023 · Event occurred Jul 7, 2023

Report 17487211 · MDR key 17487211

Device

Generic name

Counter, Sponge, Surgical

Manufacturer

Medtronic, Inc.

Model number

40161543

Patient

22265 DA · Female

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

Narrative

Description of Event or Problem

AFTER SURGICAL PROCEDURE WAS COMPLETED, SURGICAL TEAM USED THE SITUATE MAT TO SCAN FOR LAP SPONGES. THE UNIT KEPT ALARMING THAT IT "DETECTED" A SPONGE MULTIPLE TIMES. SPONGE COUNT WAS REPEATED 3 TIMES AND ALL SPONGES WERE ACCOUNTED FOR. THE TEAM THEN USED THE SITUATE HAND WAND AND IT READ "ALL CLEAR". THIS WAS REPEATED 3 TIMES ALSO. THE ATTENDING SURGEON WAS IN THE ROOM AND NOTED DEVICE HAD SAME ISSUE DAY PRIOR.