U Barth1. 1. Abteilung Medizinprodukte, Bundesinstitut für Arzneimittel und Medizinprodukte, Zitelmannstrasse 9-11, Bonn, Germany. barth@bfarm.de
Abstract
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%). CONCLUSION: 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.
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 patientinjury resulted from the reported malfunction and the investigations revealed no product error (52.7%). CONCLUSION: 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.
Authors: F Köckerling; J Rose; C Schneider; H Scheidbach; H Scheuerlein; M A Reymond; T Reck; J Konradt; H P Bruch; C Zornig; E Bärlehner; A Kuthe; G Szinicz; H A Richter; W Hohenberger Journal: Surg Endosc Date: 1999-07 Impact factor: 4.584