| Date Initiated by Firm |
January 16, 2024 |
| Date Posted |
March 22, 2024 |
| Recall Status1 |
Open3, Classified |
| Recall Number |
Z-1368-2024 |
| Recall Event ID |
94067 |
| 510(K)Number |
K152531
|
| Product Classification |
Nasopharyngoscope (flexible or rigid) - Product Code EOB
|
| Product |
InstaClear Lens Cleaner-indicated for use during routine diagnostic procedures and during endoscopic sinus surgery.
Model Number:
LCS1500UNOL
LCS1800UNST
LCS4K00UNOL
LCS1530BTOL
LCS1830BTST
LCS4K30BTOL
LCS1530TPOL
LCS1830TPST
LCS4K30TPOL
LCS1545BTOL
LCS1845BTST
LCS4K45BTOL
LCS1545TPOL
LCS1845TPST
LCS4K45TPOL
LCS1570BTOL
LCS1870BTST
LCS4K70BTOL
LCS1570TPOL
LCS1870TPST
LCS4K70TPOL |
| Code Information |
UDI-DI: N/A
All Lot Numbers |
Recalling Firm/
Manufacturer |
Olympus Corporation of the Americas
3500 Corporate Pkwy
Center Valley PA 18034-8229
|
| For Additional Information Contact |
SAME
484-896-5000
|
Manufacturer Reason
for Recall |
Japanese IFU version had slightly different language and illustrations from the English IFU, which could contribute to the tip and plate falling off. In order to maintain consistency globally, the Japanese IFU will be updated to reflect the instructions in the English IFU
|
FDA Determined
Cause 2 |
Under Investigation by firm |
| Action |
Olympus issued Urgent Medical Device Corrective Action letter on 1/16/24 to the Distributor-OLYMPUS MEDICAL SYSTEMS CORP LOGITE Tokyo, Japan for distribution to their consignees. Letter states reason for recall, health risk and action to take:
Our records indicate that your facility has purchased one or more of the affected InstaClear Sheaths. Olympus requests you to take the following actions:
1. Inspect your inventory and identify any devices with the model names specified above. Please check all areas of the hospital to determine if any of these devices remain in inventory. Add a copy of the enclosed addendum with your remaining inventory. You may continue to use the products, but this should be done in accordance with the attached labeling addendum.
2. Carefully read the content of this Medical Device Correction Action as well as the attached labelling Addendum .
3. Ensure all current and future personnel, including clinical staff, are completely knowledgeable and thoroughly aware of the contents. The Addendum provides the updated instructions for proper setup of the InstaClear Sheath.
4. Olympus requests that you acknowledge receipt of this letter [local facility method/contact].
5. If you have further distributed this product, identify your customers, forward them this notification, and appropriately document your notification process.
Actions to be taken by the company:
Olympus will update the labelling to include the improved instructions regarding proper installation and setup of the InstaClear Sheath. Additionally, your local Olympus contact will reach out to schedule an onsite educational training on setup of the InstaClear device.
|
| Quantity in Commerce |
102,279 units (OUS Only) |
| Distribution |
International distribution to the country of Japan. |
| 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 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
|
| 510(K) Database |
510(K)s with Product Code = EOB and Original Applicant = GYRUS ACMI, INC.
|
