[Incident reports with surgical staplers].
BACKGROUND
The study was initiated to evaluate the risks of surgical staplers.


METHODS
In the years 2002-2007, a total of 165 reports of incidents or corrective actions from 3 manufacturers were registered and retrospectively analyzed with respect to the prevalent product default appearance, the results of the manufacturer's investigations and the severity of the consequences for patient.


RESULTS
Severe patient consequences occurred in only 35.2%. In the majority of the cases no patient injury resulted from the reported malfunction and the investigations revealed no product error (52.7%).


CONCLUSIONS
The surgical staplers are predominantly safe for application in thoracic and abdominal surgery. The incident reports are important for risk assessment and improvement of the surgical staplers.
Barth
U
U
Abteilung Medizinprodukte, Bundesinstitut für Arzneimittel und Medizinprodukte, Zitelmannstrasse 9-11, Bonn, Germany. barth@bfarm.de
D000714:Anastomosis, Surgical; D002283:Carcinoma, Bronchogenic / Q000601:surgery; D003430:Cross-Sectional Studies; D004867:Equipment Design; D019544:Equipment Failure Analysis / Q000379:methods* / Q000706:statistics & numerical data; D017809:Fatal Outcome; D005548:Foreign-Body Migration / Q000209:etiology / Q000601:surgery; D005858:Germany; D017052:Hospital Mortality; D006801:Humans; D007422:Intestines / Q000601:surgery; D008175:Lung Neoplasms / Q000601:surgery; D011183:Postoperative Complications / Q000453:epidemiology / Q000209:etiology* / Q000401:mortality; D012086:Reoperation; D018570:Risk Assessment / Q000706:statistics & numerical data; D013528:Surgical Staplers / Q000009:adverse effects* / Q000592:standards