FDA Adverse Event Injury Summary report: N

ESOPHAGEAL TEMPERATURE PROBE 9 FR 400 SERIES

MDR report key: 3101333 · Received May 3, 2013

Report

Report Number
MW5030081
Event Type
Injury
Date Received
May 3, 2013
Date of Event
May 2, 2013
Report Date
May 3, 2013
Manufacturer
GE HEALTH CARE
Product Code
FLL
Product Problem
Yes
Report Source
Voluntary report
Reporter Location
MO, US
Reporter Occupation
NURSE

Narratives

Description of Event or Problem · 1

INTRA-OPERATIVELY GENERAL PURPOSE TEMP PROBE GAVE INACCURATE READINGS. VARIED BY 5 DEGREES/OPERATING ROOM TEAM. DAVINCI HYSTERECTOMY.

Devices

Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
195482 ESOPHAGEAL TEMPERATURE PROBE 9 FR 400 SERIES GENERAL PURPOSE TEMP PROBE FLL GE HEALTH CARE 400 SERIES 30885671

Patients

Seq Age Sex Outcome Treatment
1 36 YR Required Intervention