Model Number M00546650 |
Device Problems
Device-Device Incompatibility (2919); Adverse Event Without Identified Device or Use Problem (2993); Optical Problem (3001)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 02/13/2023 |
Event Type
malfunction
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Manufacturer Narrative
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The complainant was unable to report the serial number; therefore, the manufacture date and expiration date are unknown.Imdrf impact code f05 is being used to capture the reportable event of aborted/cancelled procedure.
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Event Description
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Note: this report pertains to a spyscope ds ii access & delivery catheters and spyglass ds - digital controller that were used in the same patient and procedure.It was reported to boston scientific corporation that a spyscope ds ii and spyglass ds - digital controller were used in the bile duct during an endoscopic biliary stone removal procedure performed on (b)(6) 2023.During the procedure, the image from the spyscope ds ii was lost approximately twenty minutes into the procedure.An electrohydraulic lithotripsy (ehl) was used in combination with the spyscope ds ii to perform lithotripsy; however, the image was lost.The procedure was not completed due to this event and was rescheduled on (b)(6) 2023.There were no patient complications reported as a result of this event.
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Manufacturer Narrative
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It was reported that the controller has been tested since this event and worked as intended.The aborted procedure is captured under mdr# 3005099803-2023-01143.
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Event Description
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Note: this report pertains to a spyscope ds ii access & delivery catheters and spyglass ds - digital controller that were used in the same patient and procedure.It was reported to boston scientific corporation that a spyscope ds ii and spyglass ds - digital controller were used in the bile duct during an endoscopic biliary stone removal procedure performed on (b)(6) 2023.During the procedure, the image from the spyscope ds ii was lost approximately twenty minutes into the procedure.An electrohydraulic lithotripsy (ehl) was used in combination with the spyscope ds ii to perform lithotripsy; however, the image was lost.The procedure was not completed due to this event and was rescheduled on (b)(6) 2023.There were no patient complications reported as a result of this event.Additional information was received on march 09, 2023: it was reported that the controller has been tested since this event and worked as intended.
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Search Alerts/Recalls
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