[41339713]
Purchased product bb060r from aesculap. The main operating room and sterile processing department (spd) was inserviced by their sales rep on how to assemble and disassemble the instrument. We followed the manufactures instructions for use (ifu) that was included with the instrument. The ifu sates that the instrument gets broken down into 3 pieces for cleaning and sterilization. We did just as it said. The operating room used it in a surgery and sent it back down to be washed and serialized. The spd again followed the ifu and broke the instrument down into 3 pieces, washed and sterilized the instrument. When the operating room opened it for a surgery a week later the instrument would not work. They played around with it and still could not get it to work. Spd was then notified that the operating room was sending down the instrument because it would not work and needed to go out for repair. At this point the spd washed the instrument and tried to figure out why it was not working. The spd and the scrub tech from the operating room could not recreate the problem. The instrument was then sent through the washing process again. This time the spd tech noticed that the instrument could actually be broken down into 4 pieces instead of the 3 pieces stated in the ifu. Upon this discovery, the entire shaft/lumen was filled with dried blood. The instrument was cleaned, but spd could not remove the blood. I pulled the instruments bb060r out of service and contacted aesculap. I spoke to the sales rep, director of regional sales and a product manager for aesculap. I called aesculap and let them know that their ifu for this instrument bb060r was incorrect and that this instrument needed to be pulled out of service until they could validate their cleaning methods and update their ifu. After multiple conversations, aesculap called and told me that there was a "cleaning flaw" in their ifu and to not use this instrument until further notice.
Patient Sequence No: 1, Text Type: D, B5