Model Number M00542251 |
Device Problem
Failure to Fire (2610)
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Patient Problems
No Consequences Or Impact To Patient (2199); No Known Impact Or Consequence To Patient (2692)
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Event Date 10/01/2019 |
Event Type
malfunction
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Manufacturer Narrative
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Date of event was approximated to (b)(6) 2019 as the event date is unknown.(b)(4).The device has not been received for analysis.Should the device become available for analysis and there is any further relevant information, 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 speeband superview super 7device was used in the esophagus during a procedure performed on an unknown date.According to the complainant, during the procedure, the suture could not release an elastic band.No patient complications have been reported due to this event.Boston scientific has been unable to obtain additional information regarding the event to date, despite good faith efforts.
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Manufacturer Narrative
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Date of event was approximated to 10/01/2019 as the event date is unknown.Problem code 2610 relates to the reportable issue of bands failed to deploy.Conclusion code 4316 is being used in lieu of an adequate conclusion code for "device not returned".According to the complainant, the suspect device has been disposed and is not available for return.If any further relevant information is received, 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 speeband superview super 7device was used in the esophagus during a procedure performed on an unknown date.According to the complainant, during the procedure, the suture could not release an elastic band.No patient complications have been reported due to this event.Boston scientific has been unable to obtain additional information regarding the event to date, despite good faith efforts.Additional information received on october 31, 2019.It was reported that the procedure performed was band ligation.There was no difficulty experienced in setting up the device.Reportedly, prior to the procedure, the suture was tangled with the bands.The procedure was completed with another speeband 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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