KENDALL SHERIDAN
Received Mar 28, 2000 · Event occurred Mar 23, 2000
Report 271247 · MDR key 271247
Device
Generic name
Esophageal Stethoscope - Sonatemp
Manufacturer
The Kendall Company LpModel number
SONATEMP SERIES 700Catalog number
CAT. #5-132185218 FR
Lot number
104955
Product problems
- Detachment Of Device Component
- Device, or device fragments remain in patient
- Material Separation
Patient
86 YR
- Vomiting
- Therapy/non-surgical treatment, additional
Narrative
Description of Event or Problem
PT IS S/P LEFT UPPER LUNG RESECTION, DONE ON 03/22/2000. AN ESOPHAGEAL STETHOSCOPE SIZE 18 FRENCH WAS INSERTED PRIOR TO SURGERY AND REMOVAL AFTER SURGERY. THIS DEVICE IS AN ANESTHESIA PRODUCT FOR TEMPERATURE MONITORING. THE NEXT DAY 03/23/2000, PT VOMITTED WHILE DRINKING SOUP AND BROUGHT UP A LATEX CAP. THIS CAP APPARENTLY CAME OFF (SEPARATED) FROM CATHETER PROBE. THE CAP IS 2 INCHES LONG AND APPEARS TO BE GLUED ON. THE PT SHOWED NO SIGNIFICANT OR OBSERVED COMPLICATIONS FROM THIS PRODUCT PROBLEM. THE MFR, KENDALL, WAS CONTACTED AND A REP CAME ON 03/24/2000 TO EVALUATE AND FILL A COMPLAINT REPORT.