Gyrus Acmi PKS Omni 5mm/33cm-intended for the electrosurgical coagulation, mechanical grasping, and dissection of tissue
Summary
The FDA issued a Class II for Gyrus Acmi PKS Omni 5mm/33cm-intended for the electrosurgical coagulation, mecha by Olympus Corporation of the Americas. Reason: Expired adhesive used as an electrical insulation barrier and as a secondary retention bond failed and could result in foreign body / biologic reacti.
Details
Source
Device Recall
External ID
Z-2380-2021
Action Date
2021-09-08
Status
Terminated
Category
device
Product Description
Gyrus Acmi PKS Omni 5mm/33cm-intended for the electrosurgical coagulation, mechanical grasping, and dissection of tissue during the performance of laparoscopic and general open surgical procedures when used in conjunction with the Gyrus ACMI G400 workstation Ref: 970010PC
Lot/Code Info: Lot number KR121617
Quantity Affected: 6 boxes (5 per/box)=30 units
Reason for Recall
Expired adhesive used as an electrical insulation barrier and as a secondary retention bond failed and could result in foreign body / biologic reaction within the patient and / or electrical continuity to patient causing tissue burn to critical structures.
Distribution
US Nationwide distribution in the states of CA, GA, MN, TN.
Type: Voluntary: Firm initiated
Recall Initiated: 2021-06-09
Company
Center Valley, PA
Context & Analysis
This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.
This was one of 126 device recalls issued in the same week, part of 413 device-related FDA actions this month.
Olympus Corporation of the Americas has 334 FDA actions in our database, including 334 recalls.
Frequently Asked Questions
What is a Class II recall?
A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (Olympus Corporation of the Americas) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Olympus Corporation of the Americas have FDA actions?
Olympus Corporation of the Americas has 334 FDA actions in our database, including 334 recalls and 0 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-2380-2021" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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