The subject devices have not been returned to omsc but were returned to (b)(4) (okm).
For evaluation.
In the evaluation of okm the following was confirmed; the bending section rubber was leaking.
The bending section was crushed, detached and rotating.
Inserting accesories to the instrument channel was restricted.
The exact cause of the reported event could not be conclusively determined at this time.
If additional information becomes available, this report will be supplemented.
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Olympus medical systems corp.
(omsc) was informed the following information.
During an unspecified procedure using the subject device, the bending section of subject device was broken.
The subject device became stuck inside patient and caused difficulty being removed from the patient.
The user tried to catheterise the patient but could not pass the catheter into the bladder because of the presence of bladder stones.
Since the subject device could not be removed from the patient, the procedure was shifted to an open surgery and the subject device was removed from the patient.
Further injuries to the patient on this event have not been reported.
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