The company is looking to replace the forceps elevator mechanism, o-ring seal and distal end covering to prevent leakage of fluids into the closed elevator channel and under the distal cap, according to the FDA release.
The federal watchdog said it cleared updated design and labeling for the duodenoscope, and that it is closely monitoring the association between so called ‘superbug’ outbreaks and the use of reprocessed endoscopes.
Pentax posted a letter it delivered to owners of the devices, instructing users to discard old copies of the operations manual and to replace them with a newly provided manual. The company also gave instructions for a return and repair of existing ED-3490TK devices.
“Pentax reminds its customers of the importance of using the ED-3490TK according to its current labeling. Customers must ensure that all reprocessing personnel are knowledgeable and thoroughly trained on the current Operation Manual and Reprocessing IFU for these devices. Meticulous cleaning of the elevator recesses and attention to following all reprocessing instructions are required. Additionally, Pentax recommends that you immediately remove from use any ED-3490TK duodenoscope that shows visible signs of wear or physical damage. Continuing to use devices with integrity issues (i.e.; holes, cracks, kinks, and scratches) can contribute to persistent device contamination and subsequent patient infection,” Pentax wrote in its letter to users of the device.