The customer reported to olympus the visera cysto-nephro videoscope curved rubber is stretched.There was no patient/user harm or injury reported due to the event.Upon device return and evaluation, it was observed that the forceps stopper cap was scraping which, is a reportable event.This medical device report (mdr) is being submitted to capture the reportable malfunction found during evaluation.
|
The device was returned to olympus for evaluation and the customer's allegation was able to be confirmed.During the device evaluation it was observed that the bending section cover (curved rubber) had slack due to stress caused by excessive squeezing or handling problem.Upon further inspection, it was observed that forceps stopper cap was scraping due to physical stress.It was also observed that the forceps channel port was shaved due to physical stress.It was observed that the connecting tube and universal cord was wrinkled due to deterioration or excessive bending.It was also observed that the bending angle in the up direction did not meet the standard value due to wear of the angle wire.It was observed that the forceps could not be inserted smoothly due to buckling or deformation of the channel.It was observed that the universal cord had a dent due to chemical or physical stress.It was also observed that the up-down plate and the switch box had discoloration due to chemical stress.Lastly, scratches were observed on the following unit components due to physical stress caused by a handling problem: video connector case, video connector, light guide connector, universal cord, lock-engagement lever, up-down plate, grip, scope connector cover, switch box and on the control unit.The investigation is ongoing.A supplemental report will be submitted upon completion of the investigation.
|