MalfunctionKLA
MCOMPASS ANORECTAL MANOMETRY CATHETER
Received Oct 10, 2023 · Event occurred Aug 31, 2023
Report 17904707 · MDR key 17904707
Device
Generic name
Monitor, Esophageal Motility, And Tube
Manufacturer
Medspira, LlcModel number
RMD-002-003Catalog number
RMD-002-003
Lot number
L-1103043
Patient
Unknown
- Insufficient Information
- Insufficient Information
Narrative
Description of Event or Problem
DIFFICULTY TROUBLESHOOTING WITH ANORECTAL MANOMETRY CATHETER X3EA FROM MEDSPIRA. THE COMPANY'S CUSTOMER SERVICE DEPARTMENT TOLD THIS REPORTER TO SEND THEM BACK TO MEDSPIRA FOR CHECKING AND REFUND FOR CATHERTER X3EA. MANUFACTURER RESPONSE FOR ANORECTAL MANOMETRY CATHETER, MCOMPASS (PER SITE REPORTER). REQUESTED FAULTY CATHETERS BE SENT TO THEM.