Parker Waichman LLP

Arthroscopic Shavers Subject of FDA Safety Alert

Medical Device Subjected To Review Arthroscopic shavers, devices that are used in some orthopedic surgical procedures, are being subjected to a Food & Drug Administration (FDA) safety review. According to the agency, there have been reports of instances in which pieces of tissue have remained within certain arthroscopic shavers, even after the cleaning process was […]

Arthroscopic Shavers

Medical Device Subjected To Review Arthroscopic shavers, devices that are used in some orthopedic surgical procedures, are being subjected to a Food & Drug Administration (FDA) safety review. According to the agency, there have been reports of instances in which pieces of tissue have remained within certain arthroscopic shavers, even after the cleaning process was believed to have been completed according to the manufacturer’s instructions.

According to an agency statement, reports have suggested that the tissue retained in arthroscopic devices was not evident to the naked eye. The FDA said it is concerned about this because retained tissue in these devices can compromise the entire sterilization process.

Understand its potential public health impact

The agency is actively working with the manufacturers of arthroscopic shavers to gather more data about this situation and to understand its potential public health impact.

The FDA said that as it obtains more information that better defines the situation and determines whether there are specific risks, it will provide that information to facilities, health care providers and the public.

According to the FDA, multiple manufacturers of arthroscopic shavers recently informed their customers of this situation and reiterated the importance of proper cleaning procedures. The FDA is encouraging facilities that use any of these types of devices to evaluate the adequacy of their cleaning procedures.

Hospitals should consider taking the following steps to minimize any potential risk to patients:

Thoroughly clean devices prior to sterilization

  • Be sure that all personnel responsible for device cleaning and sterilization at your facility are aware of and comply with all steps in the manufacturer’s instructions for thoroughly cleaning these devices prior to sterilization. Please refer to the specific instructions provided in the labeling or user manual for each brand and/or model of shaver your facility uses.
  • Consider inspecting the inside of the devices following cleaning to ensure that they have been cleared of any tissue or fluids. There may be multiple ways to accomplish this. As one example, the facility that brought this situation to our attention uses a 3mm video scope to inspect the channels of the shaver handpiece.

Finally, the agency is asking health care professionals to file a voluntary report with MedWatch, the FDA Safety Information and Adverse Event Reporting program if retained tissue is discovered in an arthroscopic shaver.

Need Legal Help Regarding Arthroscopic Shavers?

The personal injury attorneys at Parker Waichman offer free, no-obligation case evaluations. For more information, fill out our online form or call 1-800-YOURLAWYER (1-800-968-7529).

What Our Clients Say About Us
We have worked with thousands of clients and we appreciate them and their positive reviews. Here are just a few recent client reviews...
5 Star Reviews 150
Christina Morace my Paralegal at Parker Waichman’s Long Island office successfully obtained not one but two World Trade Center Victim Compensation awards for myself. She was knowledgeable, always there for me and fought for the compensation I deserved for working at Ground Zero and then unfortunately getting two 911 related ailments. I will highly recommend Christina to anyone who has to go through the Victim’s Compensation process.
Thomas McNally
7 months ago
5 Star Reviews 150
They were really professional answered all my questions walk me through the end of my case i will surely recomend to my family and friends
Malini Prasad
6 months ago
5 Star Reviews 150
A very professional Law Firm more e-mail updates would be great!
randal lee
6 years ago

Why Choose Us to Help You?

We Take Care of Everything
Your situation is stressful enough: Let us take on the deadlines, paperwork, investigation, and litigation. We'll handle every detail so you don't have to worry.
No Recovery = No Legal Fees
We work on a contingency-fee basis, meaning that we only get paid from a portion of your settlement or jury award. If you don't get compensation, you owe us nothing.
Decades of Experience
Your situation is stressful enough: Let us take on the deadlines, paperwork, investigation, and litigation. We'll handle every detail so you don't have to worry.
Respected by Our Peers
Judges, insurance adjusters, and fellow attorneys all speak highly of our skills, and we've earned numerous accolades, including a flawless rating from AVVO.
We Have Many Locations To Serve You
We have the experience and the skilled litigators to win your case. Contact us and speak with a real attorney who can help you.
Long Island – Nassau
Parker Waichman LLP
6 Harbor Park Drive
Port Washington, NY 11050
Long Island – Suffolk
Parker Waichman LLP
201 Old Country Road – Suite 145
Melville, NY 11747
New York
Parker Waichman LLP
59 Maiden Lane, 6th Floor
New York, NY 10038
Queens
Parker Waichman LLP
118-35 Queens Boulevard, Suite 400
Forest Hills, NY 11375
Brooklyn
Parker Waichman LLP
300 Cadman Plaza West
One Pierrepont Plaza, 12th Floor
Brooklyn, NY 11201
New Jersey
Parker Waichman LLP
80 Main Street, Suite 265
West Orange, NJ 07052
Florida
Parker Waichman LLP
27299 Riverview Center Boulevard
Suite 108
Bonita Springs, FL 34134
Nationwide Service
Parker Waichman LLP
59 Maiden Lane, 6th Floor
New York, NY 10038