Model Number M0054665Z0 |
Device Problems
Poor Quality Image (1408); Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 06/20/2023 |
Event Type
malfunction
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Event Description
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Note: this report pertains to the spyscope ds ii access & delivery catheter and spyglass ds controller used during the same procedure.It was reported to boston scientific corporation that a spyscope ds ii access & delivery catheter and a spyglass ds controller were used in the common bile duct during an endoscopic retrograde cholangeopancreatography (ercp) and spyglass procedure performed on (b)(6) 2023.During the procedure, the image of the spyscope ds ii was flickering and choppy throughout the case.The spyscope ds ii was unplugged and replugged into the spyglass ds controller.The controller was shut down and restarted, however, the image was not sufficient.The procedure was not completed due to this event.There were no patient complications reported as a result of this event.
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Manufacturer Narrative
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Block d4, h4: the complainant was unable to report the upn and serial number; therefore the unique identifier (udi) #, manufacture date, and expiration date are unknown.Block h6 (impact codes): imdrf impact code f1001 is being used to capture the reportable event of absence of treatment.
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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# 3005099803-2023-03980.
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Event Description
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Note: this report pertains to the spyscope ds ii access & delivery catheter and spyglass ds controller used during the same procedure.It was reported to boston scientific corporation that a spyscope ds ii access & delivery catheter and a spyglass ds controller were used in the common bile duct during an endoscopic retrograde cholangiopancreatography (ercp) and spyglass procedure performed on (b)(6) 2023.During the procedure, the image of the spyscope ds ii was flickering and choppy throughout the case.The spyscope ds ii was unplugged and replugged into the spyglass ds controller.The controller was shut down and restarted, however, the image was not sufficient.The procedure was not completed due to this event.There were no patient complications reported as a result of this event.Additional information was received on july 27, 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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