Skip to content

GYRUS ACMI, REF 3740, Everest BiCOAG Bipolar Dissecting… recallZ-1983-2013 · Gyrus Medical, Inc · initiated Jul 24, 2013

Class II Terminated All recalls posted in August 2013

Is my device affected?

  1. Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
  2. If yours is listed, follow the instructions from Gyrus Medical, Inc or your healthcare provider. The company's action is summarized under what the company is doing.
  3. Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.

Where to find your model and lot numbers · What recall classes and statuses mean

Why it was recalled

On April 29, 2013 Olympus Surgical Technologies America R&D received results from an accelerated aging study conducted as part of a new market submission. The study found that one of 60 Dissector units that underwent 3 year accelerated aging failed the dye penetration test indicating that the seal on sterile packaging was compromised. The dissector products are labeled with a 3 year shelf life.

FDA root cause category: Packaging process control

What the company is doing

Olympus sent a "Medical Device Recall" letter dated July 24, 2013, to all affected customers. The letter identified the problem the product and the action needed to be taken by the customer.. Customers were advised to immediately cease any further use of the product and remove it from inventory and quarantine it until is shipped back to the company. To return the product, call 1-888-524-7266 Olympus customer service representative. Customers were requested to complete and return by fax the enclosed questionnaire to 484-896-7128. If the product was further distributed then they need to identify their customers and notify them at once of the product recall.

Recall details

Recall number
Z-1983-2013
Recall class
Class II
Status
Terminated
Initiated by the company
Jul 24, 2013
Posted by the FDA
Aug 19, 2013
Recalling firm
Gyrus Medical, Inc
Quantity
1140
Product code
GEI
FDA submissions
K031080
Distribution
Worldwide Distribution - USA (nationwide) including the states of AL, AZ, CA, FL, GA, IL, IN, KS,KY, MD, MA, MI, MN, MS, MO, NY, NC, OH, PA, SD, TN, TX, VA and WI., and the countries of BRAZIL, CHINA, AUSTRALIA, CHINA, GERMANY and INDIA.

Product description

GYRUS ACMI, REF 3740, Everest BiCOAG Bipolar Dissecting Forceps 5mm/45 cm, Sterile EO. GYRUS ACMI, REF 3740PK, or REF 94201PK, PKS LYONS, Dissecting Forceps 5mm/45cm, Sterile EO. The Dissectors are sterile, single use electrosurgical devices that are indicated for the electrosurgical coagulation, mechanical grasping, and dissection of tissue during the performance of laparoscopic and general surgical procedures.

Code information (models, lots, serial numbers)

REF 3740  150080AC 258624MC G166568CC 381809KD 408020AE JF480565  NY492562  REF 3740PK 128971JB 226730IC 226742IC 226743IC 431894CE 431895CE G128677JB  REF 94201PK  102290EB 147428AC 167021CC 198596GC 204439HC 204451HC 249022KC 278142BD 320659DD 344712FD 363953ID 373761JD 389095MD 418231BE G386412KD G461037EE JF493195

Other devices under the same FDA submission

2 devices cleared under K031080 — the recall does not name any of them by identifier. One submission often covers many models, so they may or may not be affected.

Sources and updates

How recalls are matched to devices · Editorial policy · Report an error on this page