![]() ![]() If you or a loved one has been or may have been harmed, by a defective Proximate® reloadable surgical stapler, we would encourage you to speak with a lawyer about your legal rights. What Should You Do if You or a Loved One was Harmed by a Defective Surgical Stapler? In the letter, the FDA states that it received more than 41,000 reports related to surgical staplers between Januand March 31, 2018, including reports of more than 9,000 serious injuries and 366 deaths. Shortly before Ethicon issued the recall, the FDA sent a letter to health care providers warning of an increase in the number of adverse events associated with surgical staplers in general. Life-long nutritional and digestive issues.The need for additional closures (anastomoses).The need for additional imaging studies.The FDA states that potential risks to patients who underwent gastrointestinal surgeries performed with Ethicon’s Proximate® reloadable staplers include: Failure to cut the washer suggests complete 360-degree staple line failure.” The FDA’s recall notice from May 2019 states that Ethicon has confirmed “serious injuries to two patients,” and also notes that the recall was triggered by the investigation of multiple complaints and returned products. due to insufficient firing, which can compromise staple line integrity. In describing the reason for the recall, the FDA writes that Ethicon has confirmed, “uncut washers in the stapler and malformed staples occur. Proximate® Reloadable Surgical Staplers Recalled Due to a Critical Flaw Ethicon distributed the staplers to health care providers between Maand March 8, 2019. Just over a month later, more than 92,000 Proximate® reloadable surgical staplers had been recalled. Food and Drug Administration has classified the recall as a Class I recall, which means that, “there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death.”Īccording to the FDA, Ethicon recalled the devices, also known as endo-surgery endoscopic curved intraluminal staplers and endo-surgery endoscopic curved intraluminal staplers, on April 11, 2019. For moreinformation about any specific product, please contact the manufacturer.In 2019, Johnson & Johnson subsidiary Ethicon issued a recall for its Proximate® reloadable surgical staplers due to a flaw with the device that may have resulted in staple lines being compromised during gastrointestinal surgeries. ![]() We insist/recommend thatyou do not solely rely on the information presented and that you always readlabels, warnings, and directions before using or consuming a product. Actual product packaging and materials may contain more and/ordifferent information than that shown on our web site. Legal Disclaimer: While we take extra efforts to ensure that the displayed productinformation is correct, on occasion manufacturers may alter the productspecifications. Sterility guaranteed unless package opened or damaged.Sterile, single patient use skin stapler with 0.58 diameter.Brand : PROXIMATE® from ETHICON ENDO-SURGERY.- All clips feature proprietary lateral and transverse grooves designed for secure fixation on the structure and increased resistance to dislodgement of a formed clip.- Ethicon’s clip appliers and clips are designed to deliver superior retention, efficient ligation and minimal vessel damage.- Supports standardization & SKU reduction goals.- Ethicon is the only company with a complete portfolio of multiple clip and single clip devices for all of your open and endoscopic surgery needs.Indications : The PROXIMATE PLUS MD Skin Stapler has application for routine skin closure in a wide variety of surgical procedures.Ībout Ethicon's Efficiency and Performance: Wide staples have a diameter of 0.58mm, a span of 6.9mm and a leg length of 3.9mm. One box of Ethicon PMW35 PROXIMATE Plus MD Skin Stapler contains 6 units. The Ethicon PMW35 Skin Stapler is a high-value, low-cost skin stapler with ergonomic design. PMW35 PROXIMATE® Plus MD Skin Stapler from Ethicon Endo-Surgery, LLC (A Johnson & Johnson Company) is a multi-directional release skin stapler that contains 35 stainless steel staples.Įthicon PMW35 PROXIMATE® Plus MD Skin Stapler is a sterile, single patient use instrument designed to deliver rectangular, stainless steel staples for routine wound closure. ![]()
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