Model Number M00545000 |
Device Problem
Break (1069)
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Patient Problem
No Consequences Or Impact To Patient (2199)
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Event Date 08/08/2014 |
Event Type
malfunction
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Manufacturer Narrative
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(b)(4) for the evaluation result of wire broke.Investigation results analysis of the returned rx cytology brush did not confirm the reported complaint.The brush, working length, and the t-fitting was taken off and not returned.The distal end of the handle cannula was found to be broken.Additionally, the wire was found to be bent.Therefore, the most probable root cause is operational context since the device was difficult to use and was forcefully used and made the wire bend and break.A review of the device history record (dhr) confirmed that the device met all material, assembly, and product specifications at the time of release to distribution.A search of the complaint database confirmed that no similar complaints exist for the specified batch.
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Event Description
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Note: this event, as reported, did not reflect an mdr reportable scenario; however, evaluation of the returned device revealed an mdr-reportable malfunction.This manufacturer report is being submitted based on the evaluation results.It was reported to boston scientific corporation that an rx cytology brush was used in the pancreatic duct during a cytology procedure performed on (b)(6) 2014.According to the complainant, during the procedure, when the device was actuated, the handle cannula bent.The procedure was completed with another rx cytology brush.There were no patient complications reported as a result of this event.The patient's condition at the conclusion of the procedure was reported to be good.
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Search Alerts/Recalls
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