Another Surgical Stapler Recall
Ethicon, a medical device company, recalled its ECHELON FLEX ENDOPATH staplers this month. FDA added a MedWatch Safety Alert to its Medical Device Recalls webpage. This is a Class I recall. A Class I recall is the most serious type of recall. It is for situations “in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death.”
The recall concerns Echelon Flex Endopath staplers. These medical devices “are sterile, single patient use devices that cut and staple internal tissue.” Surgeons or other healthcare providers use them in open or in minimally-invasive surgical procedures, “including gynecologic, urologic, thoracic, pediatric, and general surgeries.” FDA Recall Page.
The October 2019, recall concerns the ECHELON Flex 60 Endopath Stapler, Articulating Endoscopic Linear Cutter (EC60A), the ECHELON Flex 60 Powered Plus Compact Articulating Endoscopic Linear Cutter (PCEE60A); the ECHELON Flex 60 Powered Plus Articulating Endoscopic Linear Cutter, 44cm Shaft Length (PLEE60A); and the ECHELON Flex 60 Powered Plus Articulating Endoscopic Linear Cutter, 34cm Shaft Length (PSEE60A).
Figuring Out if a Patient Had a Recalled Product
Patients can obtain their medical records from the place where they had their surgery. They can ask for the operative reports, implant logs, and for any other records that identify the surgical stapler that the doctor and staff used. When reviewing the medical records, patients or their healthcare providers can look for the following:
- Product Codes: EC60A, PCEE60A, PLEE60A, PSEE60A
- Lot Numbers: See specific lot numbers
These Specific Staplers are More Recent Ones
- Manufacturing Dates: July 18, 2019 – August 3, 2019
- Distribution Dates: August 1, 2019 – September 26, 2019
- Devices Recalled in the U.S.: 8,256
The reason for the surgical stapler recall is that the staples might not form correctly.
Some of these devices may contain an out of specification component within the jaw of the device, which means basically that it does not operate as intended. As a result, it could lead to malformed staples. “If a problem with the staple line is not recognized or is not adequately addressed, there is a potential risk of prolonged surgery, postoperative connection (anastomotic) leak, hemorrhage, hemorrhagic shock, additional surgical intervention, or death. As of October 3, 2019, 7 serious injuries and 1 death had been reported to Ethicon for affected product codes.”
This is One of Several Surgical Stapler Problems that FDA Identified in the Past Year
The current recall comes after another Class I recall of Ethicon surgical staplers in May. Ethicon’s last Class I recall was of its Circular Staplers. It was due to insufficient firing and failure to completely form staples.
Before that, FDA sent a letter last March to health care providers. As KBA reported previously, FDA found over 41,000 medical device reports that associated adverse events and deaths associated with the use of surgical staplers and staples for internal use between 1 January 2011 and 31 March 2018. Then in in April, FDA proposed to reclassify surgical staplers from class I (general controls) into class II (special controls). Two other medical device companies, Medtronic and J&J (which owns Ethicon) supported that reclassification.