The suspect medical device has not yet been returned to olympus for evaluation/ investigation.
Therefore, the exact cause of the patient's outcome and the reported phenomenon could not be determined and is being judged as unknown.
However, if the suspect medical device is returned for evaluation/investigation or additional significant information becomes available, this report will be updated.
Please note: this report is being submitted although the suspect medical device is not marketed in the usa.
However, a similar device is marketed.
Model # / catalog #: wb91051w; brand name: hf unit "esg-400"; common device name: hf-generators; 510(k): k141225; product code: gei.
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Olympus was informed that one day after a therapeutic transurethral resection of the prostate (turp) procedure, the patient was transferred to icu and passed away due to massive hemorrhage.
The user facility reported that the hemostasis was poor intraoperatively.
However, the turp was completed with the same set of equipment.
An on-site investigation on (b)(6) 2019 revealed that the hf cables of the generator and spare generator (ues-40) did not function correctly related to contact quality and electricity leakage.
No further information was provided.
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