It was reported that the dyonics fork suction, had a fluid leakage from the cassette due to the transducer membrane that was missing.Incident occurred before the procedure.There was no delay and a back-up device was available.All available information has been disclosed.If additional information should become available, a supplemental report will be submitted accordingly.
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H10: h3, h6: the reported device, intended for use in treatment, was returned to the designated complaint unit for independent evaluation.There was a relationship found between the returned device and the reported incident.Visual inspection of the returned device noted that the cassette is missing one transducer membrane.Functional evaluation was not performed because the visual inspection confirmed the complaint.The device would leak due to the missing transducer membrane.The complaint was confirmed and the root cause has been associated with a manufacturing error.A review of the device history records showed there were no indications to suggest that the lot did not meet manufacturing specification or would not be able to perform as intended.A complaint history review concluded this was a repeat issue.A review of the manufacturing process showed that an assembly step was missed.A correction in the form of a complaint notification has been issued to manufacturing management to mitigate future recurrences.
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