Facility reported they have been having issues with their endo smartcaps cracking and popping off their co2 insufflators.
In one instance, the smartcap popped off the water bottle and resulted in an audible noise which the doctor in the procedure room complained was very loud.
It was reported that this doctor had a hearing test done, thus potential injury is being reported.
This is the only facility medivators has received complaints from of this issue.
Medivators product specialists and sales representative visited the facility numerous times to investigate this issue and determine the cause of the endo smartcaps cracking.
It was observed and noted that the facility recently started using pdi sani-cloth af3 germicidal disposable wipes to wipe down all equipment between procedures to the point that everything is dripping wet.
The technicians would pull out approximately an arm's length of wipes and squeeze the liquid onto the carts then wipe it all over everything and allow it to air dry between procedures.
Medivators continues to investigate through internal testing of the products and continues to work closely with the facility to resolve this issue.
This facility did not disclose the hearing test documentation of the affected physician.
This is an isolated, unusual event and there have been no reports of patient harm.
Medivators will continue to monitor this complaint and it will be maintained within medivators complaint system.
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