InjuryPID
ESOFLIP ENDOLUMENAL FUNCTIONAL LUMEN IMAGING PROBE
Received Jun 13, 2024 · Event occurred Jun 12, 2024
Report MW5156267 · MDR key 19538003
Device
Generic name
Esophageal Dilator Balloon With Or Without Electrode Sensors
Manufacturer
Medtronic / Covidien LlcModel number
ES-330Lot number
23D0778JZ
Product problems
- Failure to Conduct
- Nonstandard Device
- Output below Specifications
Patient
NA · Unknown
- No Clinical Signs, Symptoms or Conditions
- No Clinical Signs, Symptoms or Conditions
Narrative
Description of Event or Problem
ESOFLIP ENDOLUMENAL FUNCTIONAL LUMEN IMAGING PROBE REFERENCE: ES-330, LOT: 23D0778JZ. RECALLED ITEM DUE TO LOW SALINE CONDUCTIVITY.
Description of Event or Problem
ADDITIONAL INFORMATION RECEIVED ON 7/15/2024 TO UPDATE MANUFACTURER.