MCOMPASS ANORECTAL MANOMETRY CATHETER
Received Jun 10, 2024 · Event occurred Apr 1, 2024
Report 19497471 · MDR key 19497471
Device
Generic name
Monitor, Esophageal Motility, And Tube
Manufacturer
Medspira, LlcModel number
RMD-002-003Catalog number
RMD-002-003
Lot number
L-1106068
Patient
NA · Unknown
- Insufficient Information
- Insufficient Information
Narrative
Description of Event or Problem
ONCE PROCEDURE BEGAN, WE PERFORMED THE FIRST 2 MANEUVERS WITHOUT INCIDENT. THEN ON THE 3RD MANEUVER, WAS RECEIVING UNUSUAL FEEDBACK ON THE SYRINGE AND WAS UNABLE TO INFLATE THE CATHETER WITH FURTHER AIR. DR ATTEMPTED TO TRY AND WAS UNSUCCESSFUL AS WELL, SHE THEN REMOVED CATHETER. THE CATHETER WAS REPLACED, AND DR DISCARDED THE FAULTY CATHETER. THE REST OF THE PROCEDURE WENT WITHOUT EQUIPMENT MALFUNCTION. MCOMPASS MEDSPIRA CATHETER LOT# L-1106068, REF# RMD002003, PART# 9000017 EXP [REDACTED DATE], DEFECTIVE - DR DISCARDED.