Device Problems
Failure To Adhere Or Bond (1031); Crack (1135); Degraded (1153)
Patient Problem
No Information (3190)
Event Date 01/03/2018
Event Type
Malfunction
Event Description
There is adhesive/glue that is applied on the distal and proximal end of the bending rubber that can cause concern of cracking or gaps in the adhesive that seals the devices distal cap to its distal tip.
It has been identified that degradation is occurring with the adhesive on olympus cystoscopes.
So far, degradation has occurred in at least 54 olympus cystoscopes, which have only been reprocessed approximately 22-23 times.