MalfunctionKLA
ESOPHAGEAL MANOMETRY CATHETER
Received Aug 17, 2018 · Event occurred Aug 14, 2018
Report MW5079232 · MDR key 7797303
Device
Generic name
Manometry Catheter
Model number
UNI-ESO-WG1A1Catalog number
CH 8544
Lot number
K123245-E-1047-D
Product problems
- Break
Patient
Not reported
- No Known Impact Or Consequence To Patient
- No Known Impact Or Consequence To Patient
Narrative
Description of Event or Problem
FOLLOWING USE, THE DIVERSATEK HEALTHCARE / SANDHILL ESOPHAGEAL MANOMETRY CATHETER WAS NOTED TO HAVE EXPOSED COPPER WIRES BELOW THE MOST PROXIMAL CATHETER MARKER BEAD.