|
Model Number A0393 |
Device Problem
Sparking (2595)
|
Patient Problem
No Consequences Or Impact To Patient (2199)
|
Event Date 06/20/2016 |
Event Type
malfunction
|
Manufacturer Narrative
|
The device was not returned to olympus for evaluation.The cause of the reported event could not be determined; however, user handling could not be ruled out as a contributing factor.The instruction manual contains several warning statements in an effort to prevent damage to the cable.¿visually inspect the cable and the plugs for irregularities on the surface.Do not use a cable with brittle or defective insulation.Replace the cable.In order to plug or unplug the cable always pull at the plug.Never pull at the cable.¿.
|
|
Event Description
|
Olympus was informed that during a transurethral resection of the prostate (turp) procedure, the high frequency (hf) cable sparked and smoked.There was no injury to the user or patient.No emergency fire evacuation took place.The procedure was completed using a different hf cable.This is report 3 of 4.
|
|
Manufacturer Narrative
|
The high frequency (hf) cable was returned to olympus for evaluation.The evaluation was unable to confirm the reported event.An olympus test working element ((b)(4)) and test generator ((b)(4)) was attached to the hf cable, and there was a consistent energy output noted at the distal end during activation.No abnormalities noted.In addition, no smoke or arcing was observed during activation.Based on the investigation findings, the root cause of the reported event could not be determined as the hf cable functioned as designed with no abnormalities.
|
|
Search Alerts/Recalls
|
|
|