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Model Number M00542251 |
Device Problems
Break (1069); Use of Device Problem (1670); Suction Problem (2170)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 11/22/2021 |
Event Type
malfunction
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Manufacturer Narrative
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(b)(4).The device has not been received for analysis.Upon receipt and completion of the problem analysis of the complaint device, if there is any further relevant information from that review, a supplemental medwatch will be filed.
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Event Description
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Note: this report pertains to the first of two speedband superview super 7 devices used in the same procedure.It was reported to boston scientific corporation that two speedband superview super 7 devices were used in the cardia during an internal hemorrhoidal ligation procedure performed on (b)(6) 2021.During the preparation, it was noticed that the suction was not enough and a crack was also observed at the tail end of the device which caused an air leakage.The same issue happened with the second speedband superview super 7 device, and 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.Additionally, it was noted that the devices were going to be expired on july 6, 2021, but the devices were used during a procedure on (b)(6) 2021.Note: according to the complainant, the speedband superview super 7 device was used in the cardia.However, per the speedband superview super 7 multiple band ligator instructions for use, the device is not intended for ligation of esophageal varices below the gastroesophageal junction.
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Manufacturer Narrative
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(b)(4).The device has not been received for analysis.Upon receipt and completion of the problem analysis of the complaint device, if there is any further relevant information from that review, a supplemental medwatch will be filed.
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Event Description
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Note: this report pertains to the first of two speedband superview super 7 devices used in the same procedure.It was reported to boston scientific corporation that two speedband superview super 7 devices were used in the cardia during an internal hemorrhoidal ligation procedure performed on (b)(6) 2021.During the preparation, it was noticed that the suction was not enough and a crack was also observed at the tail end of the device which caused an air leakage.The same issue happened with the second speedband superview super 7 device, and 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.Additionally, it was noted that the devices were going to be expired on july 6, 2021, but the devices were used during a procedure on (b)(6) 2021.Note: according to the complainant, the speedband superview super 7 device was used in the cardia.However, per the speedband superview super 7 multiple band ligator instructions for use, the device is not intended for ligation of esophageal varices below the gastroesophageal junction.
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Manufacturer Narrative
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Block h6: medical device code a0401 captures the reportable event of ligator housing was cracked.Block h10: investigation results the returned speedband superview super 7 device was analyzed, and a visual evaluation noted that the ligator head and handle assembly were returned with the device.It was noted that the ligator head was returned without the bands attached and present without issues.It was noted that the trip wire was secured, and the slack was correctly taken up.A functional evaluation was performed by rotating the handle knob 180 degrees, an audible click was heard, and indents were felt.No other problems with the device were noted.The reported event was not confirmed.Since the device showed neither evidence of the alleged issue nor any defect which could have contributed to the complaint it was concluded that the investigation conclusion code of this event 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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Note: this report pertains to the first of two speedband superview super 7 devices used in the same procedure.It was reported to boston scientific corporation that two speedband superview super 7 devices were used in the cardia during an internal hemorrhoidal ligation procedure performed on (b)(6) 2021.During the preparation, it was noticed that the suction was not enough and a crack was also observed at the tail end of the device which caused an air leakage.The same issue happened with the second speedband superview super 7 device, and 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.Additionally, it was noted that the devices were going to be expired on july 6, 2021, but the devices were used during a procedure on (b)(6) 2021.Note: according to the complainant, the speedband superview super 7 device was used in the cardia.However, per the speedband superview super 7 multiple band ligator instructions for use, the device is not intended for ligation of esophageal varices below the gastroesophageal junction.
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Search Alerts/Recalls
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