MalfunctionKLA
LATITUDE CATHETER
Received May 22, 2020 · Event occurred May 6, 2020
Report 10082540 · MDR key 10082540
Device
Generic name
Monitor, Esophageal Motility, And Tube
Manufacturer
Unisensor AgModel number
GIM6000A00Catalog number
K84AC-L-1501
Lot number
190828
Product problems
- Material Separation
Patient
4380 DA
- Device Embedded In Tissue or Plaque
- Device Embedded In Tissue or Plaque
Narrative
Description of Event or Problem
WHEN CONCLUDING A STUDY (ANORECTAL MANOMETRY TESTING) ON A PATIENT, THE BALLOON AT THE END OF THE CATHETER SEPARATED FROM THE CATHETER AND REMAINED WITHIN THE PATIENT.