inforMED
FHK

IN-FAST ULTRA

Received Jan 6, 2005 · Event occurred Jan 4, 2005

Report 565415 · MDR key 565415

Device

Generic name

Transvaginal Bladder Suspension Suturing Device

Model number

*

Catalog number

72403886

Lot number

400746

Product problems

  • Replace
  • Device Issue

Patient

*

  • Unknown (for use when the patient's condition is not known)

Narrative

Description of Event or Problem

THE SUTURING DEVICE WAS REMOVED FROM THE PACKAGE AND PREPARED FOR PATIENT USE. UPON INSERTION OF THE DEVICE, THE SURGEON ENGAGED THE ACTIVATION BUTTON AND THE DEVICE DID NOT OPERATE. REPORTED THIS TO THE VENDOR REPRESENTATIVE AND IT WAS FELT THAT THERE WAS PROBABLY A DEAD BATTERY. FOLLOW-UP REVEALS THAT ANOTHER DEVICE WAS OPENED AND USED WITHOUT INCIDENT.