Model Number M00542251 |
Device Problem
Failure to Fire (2610)
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Patient Problem
No Consequences Or Impact To Patient (2199)
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Event Date 11/19/2019 |
Event Type
malfunction
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Manufacturer Narrative
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(b)(4).Although the suspect device has been received, the evaluation has not been completed.Therefore, the cause of the reported malfunction has not been determined.Upon completion of the failure analysis of the complaint device, if there is any further relevant information from that review, a supplemental mdr will be filed.
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Event Description
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It was reported to boston scientific corporation that a speedband superview super 7 device was used in the esophagus during a band ligation procedure performed on (b)(6) 2019.According to the complainant, during the procedure, the band could not deploy.There was no difficulty experienced upon setting up the device.The procedure was completed with another speedband superview super 7 device.There were no patient complications reported as a result of this event.The patient condition at the conclusion of the procedure was reported to be stable.
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Manufacturer Narrative
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Block h6: problem code 2610 for the reportable issue of bands failed to deploy.Block h10: investigation results received one speedband superview super 7 for analysis.The ligator head and suture were not returned with the device.It was noticed that the crimp was present on the trip wire and the trip wire was secured in the handle assembly slot when received.The returned product looked in good condition without evidence of damage.A functional evaluation was performed by rotating the handle knob 180 degrees, an audible click was heard and indents were felt.No visible issue was noted with the handle assembly.Based on the evaluation of the returned device, no failures were found that could have reduced the performance of the device during the procedure.The returned device review showed no evidence of either the alleged(s) or any defect which could have contributed to the event.Therefore, the most probable root cause for this complaint is no problem detected.A review of the device history record (dhr) was performed and confirmed that this device met all material, assembly and performance specifications.
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Event Description
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It was reported to boston scientific corporation that a speedband superview super 7 device was used in the esophagus during a band ligation procedure performed on (b)(6) 2019.According to the complainant, during the procedure, the band could not deploy.There was no difficulty experienced upon setting up the device.The procedure was completed with another speedband superview super 7 device.There were no patient complications reported as a result of this event.The patient condition at the conclusion of the procedure was reported to be stable.
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Search Alerts/Recalls
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