A surgical stapler from Ethicon has been recalled due to concerns over malformed staples. These staples could cause injury or death. If a staple is malformed, it will cut off tissue and prolong the surgery. Even worse, it can cause hemorrhaging, requiring additional surgeries. After injuries and investigations, Ethicon has voluntarily recalled these staplers. Thousands of surgeries may have been performed during this time.
Surgical staplers were found to have uncut washers
In March 2019, Ethicon voluntarily recalled two types of surgical staplers due to potential safety risks. Incorrectly-fired staplers can result in poorly-formed staples, which can cause additional surgery, bleeding, or sepsis. In two cases, misfired staplers resulted in additional tissue removal during gastrointestinal surgery. The recall is the result of an investigation conducted by Ethicon, which confirmed two incidents of serious injury.
The company is a subsidiary of Johnson & Johnson and is the second-largest manufacturer of surgical staplers in the United States. Founded in 1915, Ethicon began as a company that manufactured sutures and packaged them for use in surgery. The company later acquired rival USSC, and in 1998, it changed its name to Covidien. The company’s recent acquisition of Medtronic has resulted in the production of more staplers than any other company.
They were too hard to fire
The recent recall of Ethicon Surgical Staplers was due to a high rate of failed firing. The device Ethicon Recall Lawyer failed to fire the staple correctly, resulting in malformed staples. This “insufficient firing” could also damage the staple’s integrity. Failure to fire the device properly could lead to significant injury, or even death. Two patients experienced injuries when the stapler failed to fire properly. Ethicon voluntarily recalled all Staplers that were impacted.
The FDA has a plan to increase the safety of surgical stapler devices. Surgical staples are instruments used to connect tissues during surgery. The devices have been hailed as a faster and easier alternative to traditional nylon sutures. However, there have been several reports of misapplied staples, and in some cases, even fatalities. This is why the FDA is taking action.
They caused malformed staples
The FDA has classified Ethicon Surgical Staplers as a Class I medical device recall after a number of patients experienced injuries caused by the use of these tools. Malformed staples can lead to prolonged surgery, hemorrhagic shock, and even death. Patients are advised to immediately stop using Ethicon Surgical Staplers. Affected patients should consult their medical care providers about any problems that may arise following use of these products.
In October of 2018, the FDA recalled 92,000 Ethicon Surgical Staplers because malformed staples were causing serious injuries and death. The company recalled the staplers in order to prevent any further complications from occurring. This has led to more than 32,000 defective staplers, and Burg Simpson is investigating cases of malformed staples. However, many of these staplers were still in use in hospitals.
They caused hemorrhaging
The latest recall of Ethicon Surgical Staplers has led to reports of serious injuries and at least one death. Despite the company’s claim that holding compression during staple placement will minimize bleeding, it is not known if this is really the case. The company has since issued a recall, which is currently being investigated by the FDA. Until that information becomes available, patients should avoid using Ethicon surgical staplers.
The manufacturer of Ethicon Surgical Staplers has responded to the reports of traumatic hemorrhaging and increased patient safety measures. The company has sponsored six large studies examining the ECHELON Powered Stapler. These studies showed lower incidences of bleeding complications, less operating room time and fewer all-cause readmissions within 90 days. The company also declared that patients provided written informed consent before surgery.