Olympus SD Snares, Reusable Electrosurgical Snares. Models: SD-9L/U-1, SD-11L/U-1, SD-12L/U-1, SD-13L/U-1, SD-13L/U-1, & SD-16L/U-1. Snare tube model numbers: MAJ-13 and MAJ-15. To be used with Olympus endoscopes to electrosurgically resect tissue within the digestive tract.
Recall
- Recall Number
- Z-2236-2010
- Event Number
- 55663
- Firm
- Olympus America Inc.
- FEI Number
- 2429304
- Product Code
- FDI
- Status
- Terminated
- Root Cause
- Other
- Initiated
- May 3, 2010
- Posted
- August 18, 2010
- Terminated
- May 20, 2013
- Address
- 3500 Corporate Pkwy. P.O. Box 610, Center Valley, PA, 18034-0610
Description
Olympus SD Snares, Reusable Electrosurgical Snares. Models: SD-9L/U-1, SD-11L/U-1, SD-12L/U-1, SD-13L/U-1, SD-13L/U-1, & SD-16L/U-1. Snare tube model numbers: MAJ-13 and MAJ-15. To be used with Olympus endoscopes to electrosurgically resect tissue within the digestive tract.
An investigation of consumer complaints revealed the inability of the snare wire to be retracted into the snare tube after deployment of the snare.
Firm initiated this recall following investigation of customer complaints regarding the inability of the snare wire to be retracted into the snare tube. Customers were notified via certified mail, an Urgent: Medical: Device Recall letter issued on May 4, 2010. The letter identified the affected product and the reason for the recall. Customers were instructed to inspect their inventory and identify the affected product. Customers are to remove from use any identified inventory, quarantine, and discard them. Customers should contact the firm to obtain replacement products. Questions should be directed towards Laura Storms-Tyler at 484-896-5688 or [email protected].
Nationwide Distribution -- AR, CA, CO, CT, DC, FL, GA, IN, KS, LA, MD, MO, NC, NY, OH, PA, SC, TN, and TX.
108 units