[338762]
Several months ago, during a surgery at another facility, an aesculap (davis & geck) grasper was found to be inoperable by one of the surgeons. The grasper was removed from service, tagged for repair and sent to the appropriate department. The instrument was given to a staff member for inspection and repair during the weekly routine repair visit. Several days later, the grasper was returned to the site along with debris that was found inside the instrument. Findings from the staff member indicated that the grasper had a broken o-ring, which in turn allowed debris to enter and collect in the shaft. This accumulation of debris is presumed to have caused the instrument to become inoperable. Due to the condition of the grasper and the amount of debris that was found, the site immediately informed the appropriate department, who in turn informed the risk management department and appropriate clinical personnel. At that time all graspers at this facility were pulled from service and given to the staff member with instructions to begin an intensive inspection and repair process. During the course of inspection of the remaining graspers it was discovered that a number of the site's aesculap non-ported graspers were found to have minute quantities of debris imbedded in them when there was no obvious breach or break in the o-ring. This was attributed to the deterioration of the o-rings in varying degrees. Any deteriorating or suspect o-rings were immediately replaced. A call was made immediately to the local aesculap representative and then others at aesculap requesting the most recent information on between use testing and cleaning instructions for the graspers (site had not purchased any since 2003). The first call to customer service resulted in no specific recommendations. Only after repeated calls the site was faxed a document, which specifically described the testing of the o-ring between each use. After internal discussion about the potential clinical implications of these findings, the site's appropriate department contacted the fda and the state's department of health services and informed them of the site's finding and plan of action. At this point in time, the site has completed the inspection and repair of all graspers at the institution, and are continuing the on-going investigation of the incident.
Patient Sequence No: 1, Text Type: D, B5