H10: manufacturing review: the device history records have been reviewed and this lot met all release criteria.There was nothing found to indicate there was a manufacturing related cause for this event.Investigation summary: one biopsy probe were returned for evaluation.During visual evaluation, the probe appeared clean and no other anomalies were noted on the device.It was noted that foreign material appeared on the trocar tip.An enspire system and in-house saline cap were used for functional testing.Upon functional testing, the probe was loaded into the driver and calibrated successfully.The probe passed in maximum vacuum test and failed in vacuum differential test.The probe was inserted into a piece of beef and around the clock sampling was performed.The probe was able to obtain 6 samples successfully.Therefore, the investigation is confirmed for the reported foreign material and identified filling issue as foreign material was found on the trocar tip and the probe fails to meet the requirement of vacuum differential test.However, the investigation is unconfirmed for the reported suction issue as the device meets the requirement of maximum vacuum test.A definitive root cause for the reported failure could not be determined based upon the provided information.Labeling review: a review of product labeling documentation (e.G., procedural instructions, indications, warnings, precautions, cautions, possible complications, contraindications, nursing guide, and unit label) did not find any product labeling inadequacy.H11:section a through f - the information provided by bd represents all of the known information at this time.Despite good faith efforts to obtain additional information, the complainant / reporter was unable or unwilling to provide any further patient, product, or procedural details to bd.
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