The subject device has not been returned to olympus medical systems corp.(omsc) for investigation.The exact cause could not be conclusively determined.As the result of checking the manufacturing record of the same lot, there was nothing abnormal detected.A supplemental report will be submitted, if additional and significant information becomes available at a later time.Cross reference mfr.Report number: 8010047-2016-00389, 8010047-2016-00390.
|
Three subject devices were used for treatment of the varix.The subject devices had no malfunction before using them.The doctor attempted to inject the adrenalin, but the adrenalin could not be come out.He attempted to retract the needle tube in the tube sheath for the exchange of the device.But the needle tube could not be retracted.Three of them had the similar malfunction.As a result, the doctor could not stop bleeding.It was unknown whether the procedure was completed or not.However, as a result of additional investigations, olympus medical systems corp.(omsc) found that no patient's serious injury was reported.In addition, the doctor commented that he could not inject the adrenalin due to kinking of the subject device.This is the first of the three reports.
|
This supplemental report is being submitted to provide additional information based on the evaluation of the returned device.Section model and lot #, device available for evaluation?, date received by mfr, type of reports, i follow-up, what type?, device evaluated by mfr, device manufacture date, evaluation codes were updated.The subject device was returned to olympus medical systems corp.(omsc) for evaluation.The needle tube could be extended and retracted.However, the movement of the extending and retracting was not smooth.The insertion portion was kinked.As the result of checking the manufacturing record of the same lot, there was nothing abnormal detected.Based on the evaluation of the subject device and the similar cases in the past, retraction failure of the needle tube might be caused by increasing of frictional resistance between the tube sheath and the needle tube.Increasing of frictional resistance might be caused by kinking of the insertion portion.The kinking might be caused by excessive load given to the device while inserting and withdrawing the device to the scope.The instruction manual of the subject device already states; insert the instrument slowly.Abrupt insertion could damage the endoscope and/or instrument.Cross reference mfr.Report number: 8010047-2016-00389, 8010047-2016-00390.
|