This is a supplemental report to provide additional information.The subject device was returned to olympus medical systems corp.(omsc) for evaluation.The handle and the operation pipe inside the handle were broken off.The broken surface of the handle was mechanical cutting with tools.The broken surface of the operation pipe was ductile fracture.The loop and the hook were retracted into the coil sheath.The loop was broken off.The hook was not deformed.The manufacturing record was reviewed and found no irregularities.Based on the past similar cases, it was known that this event occurred since the loop was caught between the hook and the coil sheath after the loop was released in the tube sheath for unspecified reason.The above device handling has warned in the instruction manual as follows.Do not try to forcibly withdraw the instrument from the endoscope when the loop cannot be detached from the instrument.Forcibly withdrawing the instrument could cause patient injury such as punctures, hemorrhages or mucous membrane damage.If the loop cannot be detached from the instrument, follow the procedures described in this section.If there are any deviations or crushed sections on the distal end of the coil sheath, it may not be possible to detach the loop from the instrument.Do not remove the loop from the hook while the coil sheath is not extended from the tube sheath.Otherwise, the loop may be tangled with the hook and become impossible to be removed.
|