Late in the summer of 2018, several surgeons at McLeod Regional Medical Center in Florence, South Carolina, grew increasingly concerned about the quality of a vital surgical tool they relied on in their operating rooms. The GIA 80 surgical skin stapler, produced by Covidien, a subsidiary of medical tech giant Medtronic, did not properly hold incision edges together or the internal knife malfunctioned during appendectomies and other critical surgeries, the doctors said. This led to unnecessary and sometimes dangerous bleeding in patients.

In September 2018, Cary Brewton, a McLeod general surgeon, wrote on a product complaint form that “as stapler approximated, it tore SB [the patient’s small bowel]” three times. Each time, Brewton had to cut out more of the bowel to repair the tears, he wrote. “UNACCEPTABLE,” Brewton added in capital letters on the complaint form. He suggested that the medical center return to a type of stapler they had used previously — one produced by a Medtronic competitor — that hadn’t caused such problems.