Model Number M00542251 |
Device Problem
Misfire (2532)
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Patient Problem
No Consequences Or Impact To Patient (2199)
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Event Date 11/21/2018 |
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 variceal ligation procedure performed on (b)(6) 2018.According to the complainant, during the procedure, the band fell when deploying.The procedure was completed with another speedband superview super 7 device.There were no patient complications reported as a result of this event.
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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 variceal ligation procedure performed on (b)(6) 2018.According to the complainant, during the procedure, the band fell when deploying.The procedure was completed with another speedband superview super 7 device.There were no patient complications reported as a result of this event.
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Manufacturer Narrative
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Block h6: problem code 2532 relates to the reported issue of band misfired.Block h10: investigation results: received one speedband superview super 7 for analysis.The ligator head was not returned with the device.It was noticed that the crimp was present on the trip wire.A visual examination of the device found that the trip wire was secured in the handle assembly slot when received.The suture was intact and attached to the trip wire loop.A functional evaluation was performed by rotating the handle knob 180 degrees, an audible click was heard and indents were felt.No issue was noted with the handle assembly and the returned product looks in good conditions without evidence of damages.Based on the evaluation of the returned device, the device showed neither evidence of the alleged issue nor any defect which could have contributed to the complaint.Therefore, it was concluded that the investigation conclusion code of this event is "no problem detected" since the device complaint or problem cannot be confirmed.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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Search Alerts/Recalls
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