inforMED
MalfunctionLWH

SITUATE

Received May 12, 2021 · Event occurred Apr 8, 2021

Report 11811741 · MDR key 11811741

Device

Generic name

Counter, Sponge, Surgical

Manufacturer

Medtronic

Product problems

  • Device Sensing Problem

Patient

23725 DA

  • Insufficient Information
  • Insufficient Information

Narrative

Description of Event or Problem

THE PATIENT UNDERWENT A TWO-PART PROCEDURE (ABDOMINOPLASTY AND MINI FACE/NECK LIFT). FIRST PROCEDURE WAS ON THE FACE AND A COUNT WAS CONDUCTED WHEN CLOSING THE FACE. THE PATIENT WAS SCANNED USING THE SITUATE WAND AND THE WAND INDICATED A CLEAR READ. THE PATIENT WAS THEN RE-PREPPED AND DRAPED FOR SECOND PORTION OF SURGERY. A FULL COUNT WAS DONE AND A SCAN WAS CONDUCTED WITH THE SITUATE MAT, SINCE IT WAS AN ABDOMEN PROCEDURE. THE MAT INDICATED A DETECTION. COUNTS WERE REDONE AND CORRECT TWICE. THE TABLE AND MAYO STAND WERE MOVED FROM THE FIELD TO ENSURE NO INTERFERENCE. SCAN REPEATED AND OPERATOR STILL RECEIVED DETECTION READING FROM THE MAT. A SCAN WAS THEN PERFORMED USING THE SITUATE WAND AND THE SCAN READ CLEAR. COUNTS WERE CORRECT MULTIPLE TIMES. AFTER THE PROCEDURE ONCE THE PATIENT WAS MOVED FROM BED TO STRETCHER, OPERATOR TRIED TO SCAN BED WITH SITUATE MAT SEVERAL TIMES. EACH TIME, THE MAT WAS DETECTING, DESPITE NOTHING BEING ON THE BED.