The subject device was inspected.The complaint was confirmed.The unit failed the probe function test with error message.Transducer buttons do not work, transducer does not turn on/ no output , no correct function of the transducer were observed during the initial evaluation at rrc (regional repair center) (b)(6).There was no physical damage noted during the device initial evaluation in ter (technical evaluation report) from ode rrc (regional repair center) at (b)(6), however, the suction port damage was observed during the mbc (manufacturing business center) service repair device inspection.The damage noted may be caused by improper handling during transportation.Based on inspection results, the probable cause of the reported failures cannot be determined at this time.Dhrs (device history records) for this product have been reviewed.This unit was manufactured on 12oct2020.All records indicate that the product was manufactured and tested in accordance with all applicable procedures and met all final product release criteria.The shockpulse ifu (instructions for use)_rev an states, "perform the prescribed inspections prior to first use and regularly thereafter to ensure continued satisfactory performance." (2.4.1 general, page 9); "back-up transducer and probe should be sterilized and available prior to beginning a procedure." (cautions, page 4); "the operator should ensure the probes, generator, transducer, and accessories are undamaged prior to beginning any procedure." (9.1 general checks, page 35) olympus will continue to monitor the field performance of this device.
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Device was returned for inspection due to customer reported issue of ¿sonotrodes not recognized¿, no function.The issue found during an unknown event.There is no patient involvement associated on this reported event.No user injury reported.Device return evaluation found damaged suction port.This report is being submitted, reported due to damaged suction port, use handling issue.This report is related to a report with patient identifier (b)(6).
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