Z-1699-2024Class II
POWERSEAL 5 mm, 23 cm, Curved Jaw Sealer and Divider, Double Action is indicated for use in general surgery...
OLYMPUS Corporation of the Americas / initiated 2024-03-07 / Open, Classified / root cause: manufacturing process
Olympus Corporation of the Americas began a recall of POWERSEAL 5 mm, 23 cm, Curved Jaw Sealer and Divider, Double Action is indicated for use in general surgery and such surgical specialties as urologic... on . FDA classified it as Class II and gives the reason as "Upon initial activation of the seal function, the POWERSEAL non-conformance results in an immediate Incomplete Seal Cycle tone with the accompanying message on the generator screen, and no energy would be delivered to...". As of , the recall status on record is Open, Classified, and MDM tags the root cause as manufacturing process.
Recall record
- Recall number
- Z-1699-2024
- Classification
- Class II
- Status
- Open, Classified
- Initiated
- Posted
- Recalling firm
- OLYMPUS Corporation of the Americas
- Product
- POWERSEAL 5 mm, 23 cm, Curved Jaw Sealer and Divider, Double Action is indicated for use in general surgery and such surgical specialties as urologic, colorectal, bariatric, vascular, thoracic, and gynecologic. Model/Catalog Number: PS-0523CJDA
- Product code
- GEI Electrosurgical, Cutting & Coagulation & Accessories
- Reason for recall
- Upon initial activation of the seal function, the POWERSEAL non-conformance results in an immediate Incomplete Seal Cycle tone with the accompanying message on the generator screen, and no energy would be delivered to the device resulting in delay in surgery.
- Root cause tag
- manufacturing process
- FDA root cause
- Process control
- Action
- Olympus issued Urgent Medical Device Removal Letter on April 2, 2024 via email/visit. Letter states reason for recall, health risk and action to take: 1. Inspect your inventory and identify any POWERSEAL products having the lot number identified above. Please check all areas of the hospital to determine if any of these devices remain in inventory. Quarantine and cease use of the affected model/lots. 2. Please contact Customer Service at at 1-800-848-9024, option 2, with the quantity, model and lot number of the affected device(s). Olympus will issue a Return Material Authorization to return any affected product at no charge. Olympus will issue a credit to your facility upon return of the affected product. 3. Access the Olympus recall portal to indicate that you have received this notification. a. Go to https://olympusamerica.com/recall b. Enter the recall number "0444 . c. Complete the form as instructed and include your account ID number. 4. If you have distributed these devices outside your facility, please provide a copy of this letter to those facilities immediately. If you require additional information, please do not hesitate to contact me directly by phone at (647) 999-3203 or by e-mail at [email protected]
- Quantity in commerce
- 160 units: (20 units US); (140 units OUS)
- Distribution
- Worldwide distribution - US Nationwide and the countries of AU, CA, HK, KR.
- Product codes and lots
- UDI-DI: 00821925044531 Lot number: CA182554
Enforcement reports
One row per recalled product line| Recall number | Class | Status | Voluntary or mandated | Report date | Classified |
|---|---|---|---|---|---|
| Z-1699-2024 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-1700-2024 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-1701-2024 | Class II | Ongoing | Voluntary: Firm initiated |
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