It was reported, that the subject device made a popping sound and sparked, and the cable was burned and broken.The issue occurred during a therapeutic transurethral resection of the prostate in saline (turis) procedure.The procedure was completed using a similar device.There were no reports of patient harm.
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This supplemental report is being submitted to provide the results of the legal manufacturer's final investigation.B5 was corrected.Additional information added to fields d8, d9, h3, and h6.A review of the device history record found no deviations that could have caused or contributed to the reported issue.It has been over 6 years since the subject device was manufactured.The device was returned to olympus for inspection, and the customer's complaint was confirmed.Based on the results of the investigation, it is likely the following led to the malfunction: the age-related wear and tear in connection with repeated strong bending or tensile loads most likely led to the breakage of individual or all strands in the cable.The event can be detected/prevented by following the instructions for use: firstly, the lifespan of the cable is limited to 12 months.After this time, the cable should not be used any more.Furthermore, the cable must be checked for damage before each use and after reprocessing.By gently pulling on the plug (max.20n), it can be determined whether the copper strand of the cable is damaged.If the cable does not give way but remains rigid, it is highly likely that the cable is ok at this point.In order not to further shorten the lifespan of the cable, the cable should not be wound up with a loop diameter of less than 10 cm and when pulling out the cable, the plug should be pulled and not the cable.Olympus will continue to monitor field performance for this device.
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It was reported, that the subject device made a popping sound and sparked, and the cable was burned and broken.The issue occurred during a therapeutic transurethral resection of the prostate in saline (turis) procedure.The procedure was completed using a similar device after a five minute delay.There were no reports of patient harm.
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