inforMED

LIFESOUND

Received Feb 24, 2006 · Event occurred Oct 1, 2005

Report 691559 · MDR key 691559

Device

Generic name

Stethoscope Esophogeal

Manufacturer

Novamed

Model number

1520 18FR

Catalog number

10-1520-040

Lot number

*

Product problems

  • Design/structure problem

Patient

32 YR

  • Abdominal Pain
  • Surgical procedure
  • Foreign body, removal of

Narrative

Description of Event or Problem

FEMALE PATIENT UNDER GENERAL ANESTHESIA UNDERWENT A PROCEDURE THAT REQUIRED THE USE OF AN ESOPHAGEAL STETHOSCOPE AND ENDOTRACHEAL TUBE. SOME TIME AFTER THE PROCEDURE THE PATIENT COMPLAINED OF VAGUE ABDOMINAL PAIN AS HER FIRST SYMPTOM. TWO WEEKS LATER THE ESOPHAGEAL STETHOSCOPE WAS DETECTED ON A CAT SCAN AND WAS REMOVED VIA AN ENDOSCOPE. UNKNOWN TO THE STAFF, THE STETHOSCOPE DURING THIS CASE WAS SWALLOWED BY THE PATIENT. IT IS SUGGESTED THAT THE MANUFACTURER REEVALUATE THEIR CURRENT DESIGN TO INCORPORATE A MEANS OF PREVENTING THE PATIENT FROM SWALLOWING THE DEVICE.