The FDA is warning healthcare providers about the risk of serious injury, malfunction and death associated with surgical staplers and implantable surgical staples. Between January 2011 and March 2018, ...
Ottawa, May 06, 2025 (GLOBE NEWSWIRE) -- In terms of revenue, the surgical staplers market is worth USD 6.14 billion in 2025 and is anticipated to reach around USD 6.56 billion in 2026. The market is ...
The US Food and Drug Administration (FDA) on Thursday reclassified surgical staplers and staples for internal use from Class I (general controls) to the more stringent Class II (special controls) ...
FDA issues a safety communication on Intuitive Surgical's curved tip staplers after reports of serious injuries. Regulators flag potential safety, reputational, and operational risks tied to the ...
Tens of thousands of surgical staplers for internal use have been associated with serious adverse events, prompting a new proposal from the US Food and Drug Administration (FDA) to reclassify the ...
Surgical staplers are specialized staplers used in surgery in place of sutures to perform anastomosis in an efficient and sterile manner. Since their development in 1908, innovations in surgical ...
The report is intended to predict what issues will be important in the coming year and make practical recommendations to hospitals to prevent them, said Robert Schluth, senior project officer of ...
The Food and Drug Administration has acknowledged that more than 56,000 never-before-disclosed surgical stapler malfunctions were quietly reported to the agency from 2011 through 2018. The newly ...
Stapler maker Medtronic confirmed that its reporting exemption for surgical staples ended in mid-2017. FDA records show that its public reports of injuries and malfunctions soared, from about 1,000 in ...
Stapler maker Medtronic confirmed that its reporting exemption for surgical staples ended in mid-2017. FDA records show that its public reports of injuries and malfunctions soared, from about 1,000 in ...
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