29 results

• FDA Hopes To Improve Surgical Staplers Safety Through New Rules And Guidance

  April 25, 2019

  Irvin Jackson

  The FDA has proposed reclassifying surgical staplers as moderate risk medical devices and asks manufacturers to place more stringent label warnings on them to lower the high rate of complications being reported.

• Surgical Stapler Problems Linked to More Than 9,000 Serious Injuries and 366 Deaths, FDA Warns

  March 11, 2019

  Irvin Jackson

  The FDA has issued a new warning to doctors about the risks of surgical staplers, and will hold a public hearing and issue new guidance on their safety and use later this year.

• Ethicon Stapler Lawsuit Results in $80M Jury Award

  December 16, 2015

  Irvin Jackson

  A San Jose woman and her husband have been awarded $9.8 million in a lawsuit against Ethicon for manufacturing a defective surgical stapler which caused her serious abdominal injuries.

• TigerPaw Surgical Staple Recall Issued Over Risk of Tears, Bleeding in Heart

  May 8, 2015

  Russell Maas

  A surgical stapler used for heart surgery is being recalled following at least one death and dozens of injuries linked to failures of the device to close heart wounds.

• Ethicon Proximate Stapler Lawsuit Filed Over Misfire During Surgery

  February 28, 2014

  Irvin Jackson

  An Ethicon Proximate stapler lawsuit filed by a Michigan man claims that the recalled surgical staplers were defective, causing him to suffer severe and permanent injuries.

• FDA Warns of Stolen Unsterilized Covidien Surgical Staples

  May 8, 2013

  Martha Garcia

  After a batch of surgical staples were stolen from a Covidien manufacturing facility, the FDA has issued a safety advisory...

• Ethicon Endo-Surgery Circular Stapler Recall Issued Due to Complications

  October 29, 2012

  Russell Maas

  More than 157,000 Ethicon surgical staplers have been recalled, due to problems with incomplete firing strokes that may cause faulty...

• Ethicon Proximate Stapler Recall Issued Due to Risk of Misfire

  August 13, 2012

  Irvin Jackson

  In response to reports where doctors have had problems with Ethicon Endo-Surgery staplers, more than 500 lots of the Proximate...

• Covidien Roticulator Surgical Stapler Recall Due To Contamination Risk

  May 21, 2012

  Staff Writers

  Covidien has issued a recall of Roticulator single-use surgical staplers, due to potential sterility issues that may pose an infection...