CYSTOURETHROSCOPE STANDARD OBTURATOR
Received Oct 3, 2013 · Event occurred Aug 18, 2013
Report 1519132-2013-00026 · MDR key 3466445
Device
Generic name
Cystourethroscope Standard Obturator
Manufacturer
Gyrus Acmi, Inc.Model number
E121-OCatalog number
E121-O
Product problems
- Break
- Detachment Of Device Component
- Component Falling
Patient
28 YR
- Device Embedded In Tissue or Plaque
Narrative
Additional Manufacturer Narrative
AT THE TIME OF THIS REPORT, THE DEVICE HAS NOT YET BEEN RETURNED FOR EVAL. AS A RESULT, A DETERMINATION CANNOT BE MADE AT THIS TIME. IF FURTHER INFO BECOMES AVAILABLE, GUYRUS ACMI WILL CONTINUE THE INVESTIGATION AND UPDATE THE AGENCY ACCORDINGLY.
Description of Event or Problem
GYRUSACMI WAS NOTIFIED VIA A UF MEDWATCH THAT THE PLASTIC TIP OF THE SHEATH DEVICE USED IN A CYSTOSCOPY PROCEDURE BROKE OFF AND APPARENTLY FELL INTO VAGINAL FOLDS. BROKEN OFF PLASTIC TIP FELL OUT OF THE PT A FEW HOURS AFTER THE PROCEDURE. NO INJURY OR ADDITIONAL PROCEDURE REQUIRED FOR THE PT.