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.
FDA Recall Z-2236-2010 · Posted 2010-08-18
Recalling FirmOlympus America Inc.
Recall StatusTerminated
Product CodeFDI
Date Initiated2010-05-03
Date Terminated2013-05-20
Product Quantity108 units
Reason for Recall
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 Action
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].
Root Cause
Other
Distribution Pattern
Nationwide Distribution -- AR, CA, CO, CT, DC, FL, GA, IN, KS, LA, MD, MO, NC, NY, OH, PA, SC, TN, and TX.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.