MalfunctionDTS

NOVOSCI

Received Jul 21, 2005 · Event occurred Jun 1, 2005

Report 1625519-2005-00002 · MDR key 742492

Device

Generic name

Adult Sump Sucker

Manufacturer

Novosci Corp.

Model number

Catalog number

201090NS

Lot number

278038

Product problems

Tip breakage

Patient

No Consequences Or Impact To Patient

Narrative

Description of Event or Problem

SUCKER BROKE DURING SURGERY. TIP WAS RETRIEVED. NO REPORT OF PATIENT INJURY.

Additional Manufacturer Narrative

H6: SUCKERS ARE TESTED DURING MANUFACTURING FOR BEND STRENGTH TEST. DIRECTIONS FOR USE FOR SUCKERS STATE "IT IS NOT INTENDED TO BE USED AS A PROBE OR RETRACTOR." PRODUCT IS SUPPLIED TO ANOTHER MANUFACTURER WHERE IT RECEIVES FURTHER PROCESSING. PRODUCT MET SPECIFICATIONS.