FDA issues surgical stapler warning — 5 insights

Written by Eric Oliver | March 11, 2019 | Print  |

The FDA issued a warning on surgical staplers after receiving a growing number of medical device reports, Medscape reports.

What you should know:

1. The FDA received more than 41,000 individual MDRs for surgical staplers and staples from Jan. 1, 2011 to March 31, 2018.

2. Among those MDRs, there were 366 deaths, more than 9,000 serious injuries and more than 32,000 malfunctions.

3. Malfunctions may result in prolonged surgical procedures and unplanned interventions; both could cause other complications including bleeding, sepsis, internal tissue tearing, increased cancer recurrence risk and death, in some cases.

4. The FDA recommends surgeons review surgical staplers and implantable staples instructions and indications before using either device. The FDA also suggests surgeons consider alternate options if a patient's tissues are swollen, bleeding prone or necrotic.

5. The FDA plans to issue draft guidance with labeling recommendations in the coming months. The FDA is also going to hold a public advisory committee meeting to discuss the appropriateness of current related-pathways and weigh converting staplers into a class 2 device.

More articles on devices: 
Orthofix earns FDA premarket approval for M6-C artificial disc
38 orthopedic devices receive FDA 510(k) clearance in February
Alphatec reports 9.9% drop in 2018 revenue, secures $30M in additional financing

© Copyright ASC COMMUNICATIONS 2019. Interested in LINKING to or REPRINTING this content? View our policies here.

Top 40 Articles from the Past 6 Months