BERKELEY, CA (UroToday Inc.) - Many surgeons use surgical staplers. Applications include ligation, division, resection, anastomosis and fascial closure. To complete these tasks, different types of staplers are used. Adverse events may result from use of these instruments.

Dr. S. Lori Brown and Ms. Eileen K. Woo from the Center for Devices and Radiological Health of the Food and Drug Administration, Rockville MD, report on fatalities and adverse events associated with surgical staplers. Their findings appear in the September 2004 issue of the Journal of the American College of Surgeons.

All medical reports associated with surgical staplers or clip appliers filed with the Manufacturer and User Facility Device Experience database by 2001 were retrieved. In addition, death reports related to use of endoscopes or accessories and laparoscopic procedures were culled to index any additional events.

Reports of death occurring postoperatively when surgical staplers were used were identified in 112 patients. 65%, 19%, 5.4% and 4.5% of these occurred in gastrointestinal, thoracic, cardiovascular and hepatic/kidney/spleen cases, respectively. Staples not forming, device failure and suture line separation were the most commonly reported problems. Anastomotic failure, prolonged or repeat surgery, bleeding and infection accounted for 40%, 31%, 29% and 23% of reported patient problems.

Between 1992 and 2001, 2,180 reports of patient injury and 17,687 reports of device malfunction were reported with surgical staplers.

The authors found 22 recalls of stapling devices or components. Reasons included sterility issues, manufacturing issues or design issues.

Urologists primarily use surgical staplers for ligation and division of vascular pedicles, such as during cystectomy, or ligation and reanastomosis of bowel during urinary diversion. Anastomotic intestinal leak is a significant complication that we may encounter therefore. Tips to avoid this complication include: not overlapping staple lines, reinforcing the end of staple lines with silk suture (although staple manufactures do not advocate this) and testing the anastomosis for leaks by applying manual compression to the proximal and distal intestine.

Likely many urologists have experienced problems with the staplers, but they do not report them. These FDA authors remind us of the importance of this reporting, so that accurate records can be maintained.

J Am Coll Surg. 2004;199:374-81