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U.S. Department of Health and Human Services

Class 2 Device Recall Olympus SD Snares

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  Class 2 Device Recall Olympus SD Snares see related information
Date Initiated by Firm May 03, 2010
Date Posted August 18, 2010
Recall Status1 Terminated 3 on May 20, 2013
Recall Number Z-2236-2010
Recall Event ID 55663
510(K)Number K955650  
Product Classification Flexible Snare - Product Code FDI
Product 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.
Code Information Snare Package Lot numbers: 9YK, 9ZK, 01K, 02K, & 03K.  Snare Tube Lot Numbers: K9Y10, K9Y16, K9Y18, K9Y19, KDY20, K9Y24, K9Y25, K9Y26, K9Y27, K9Y30,K9Z01, K9Z02, K9Z03, K9Z04, K9Z07, K9Z08, K9Z09, K9Z10, K9Z11, K9Z14,K9Z15, K9Z16, K9Z17, K9Z18, K9Z21, K9Z22, K9Z24, K9Z25, K9Z28, K9Z29, K0105, K0106, K0107, K0108, K0112, K0113, K0114, K0115, K0118, K0119, K0120, K0121, K0122, K0127, K0129, K0202, K0203, K0204, K0205, K0208, K0209, K0210, K0212, K0215, K0216, K0217, K0218, K0222, K0224,K0225, K0226, K0301, K0302, K0303, K0305, K0308, K0309, K0310, K0311, K0312, K0315, and K0316. 
Recalling Firm/
Manufacturer		 Olympus America Inc.
3500 Corporate Pkwy.
P.O. Box 610
Center Valley PA 18034-0610
For Additional Information Contact Laura Storms Tyler
484-896-5688
Manufacturer 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.
FDA Determined
Cause 2		 Other
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 laura.storms-tyler@olympus.com.
Quantity in Commerce 108 units
Distribution Nationwide Distribution -- AR, CA, CO, CT, DC, FL, GA, IN, KS, LA, MD, MO, NC, NY, OH, PA, SC, TN, and TX.
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database 510(K)s with Product Code = FDI and Original Applicant = OLYMPUS AMERICA, INC.
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