OLYMPUS BALLOON 3 FOR ULTRASONIC ENDOSCOPE
Received Jul 15, 2011 · Event occurred May 13, 2011
Report 8010047-2011-00158 · MDR key 2224257
Device
Generic name
Balloon
Manufacturer
Olympus Medical Systems Corp.Model number
MAJ-249Catalog number
5295630
Lot number
13H/2011090
Product problems
- Material Perforation
Patient
Not reported
- No Information
Narrative
Description of Event or Problem
OLYMPUS RECEIVED A MEDWATCH REPORT, WHICH STATED: "DURING A BALLOON FOR ULTRASONIC ENDOSCOPE PROCEDURE, SIX (6) BALLOONS WERE PUT ON ENDOSCOPE AND HAD HOLES IN THE SAME AREA. FOUR OF THE 6 WERE RETRIEVED. THE REST OF THE BAG OF 20 WERE NOT USED AND SEQUESTERED".
Additional Manufacturer Narrative
OLYMPUS FOLLOWED-UP WITH THE USER FACILITY VIA PHONE AND IN WRITING TO OBTAIN ADDITIONAL INFORMATION, HOWEVER NO ADDITIONAL INFORMATION WAS PROVIDED. THE DEVICES REFERENCE IN THIS REPORT WERE NOT RETURNED TO OLYMPUS. REVIEW OF COMPLAINT FILES IDENTIFIED NO OTHER COMPLAINTS FOR THIS LOT. THE CAUSE OF THE REPORTED EVENT COULD NOT BE CONCLUSIVELY DETERMINED. OLYMPUS WILL CONTINUE TO INVESTIGATE THIS MATTER AND THIS REPORT WILL BE SUPPLEMENTED. THIS REPORT IS BEING SUBMITTED AS A MEDICAL DEVICE REPORT IN AN ABUNDANCE OF CAUTION.