Model Number M0054665R0 |
Device Problem
Poor Quality Image (1408)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 06/22/2023 |
Event Type
malfunction
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Event Description
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Notes: this report pertains to two spyscope ds ii complaints and spy ds controller used during the same procedure.It was reported to boston scientific corporation that two spyscope ds ii complaints and spy ds controller were used during a cholangioscopy procedure performed in the bile duct on (b)(6) 2023.During preparation, the customer tried to insert two spyscope ds ii of different batch number, but the controller did not recognize any of the spyscope ds ii.They tried to turn the controller on and off for several times and also disconnecting and reconnecting the power supply, however; the problem was not resolved.The procedure was not completed due to this event and reschedule on (b)(6) 2023.There were no reported patient complications as a result of this event.
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Manufacturer Narrative
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Block h6 (impact codes): imdrf impact code f1001 is being used to capture the reportable event of aborted/cancelled procedure.
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Event Description
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Notes: this report pertains to two spyscope ds ii complaints and spy ds controller used during the same procedure.It was reported to boston scientific corporation that two spyscope ds ii complaints and spy ds controller were used during a cholangioscopy procedure performed in the bile duct on (b)(6) 2023.During preparation, the customer tried to insert two spyscope ds ii of different batch number but the controller did not recognize any of the spyscope ds ii.They tried to turn the controller on and off for several times and also disconnecting and reconnecting the power supply, however; the problem was not resolved.The procedure was not completed due to this event and reschedule on (b)(6) 2023.There were no reported patient complications as a result of this event.
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Manufacturer Narrative
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Block h6 (impact codes): imdrf impact code f1001 is being used to capture the reportable event of aborted/cancelled procedure.Block h10: investigation results the returned spyglass digital controller was analyzed by enercon technologies, and the evaluation noted that the front panel has finish defects.Confirmed the video would cut in and out as the scope was moved.The catheter interface contacts have unknown contamination and are causing the intermittent video.The contacts require replacement to repair this unit.The issue was verified according to product analysis.Per the evaluation conducted by enercon technologies, the reported complaint was confirmed.Although the number of procedures/recycles of the unit are unknown, improper handling of the device or wear/tear on internal components over time likely contributed to the event.Based on all gathered information, the conclusion code selected for this event is cause traced to maintenance, which indicates that problems are traced to improper routine or preventative maintenance.A labeling review was performed and, from the information available, this device was used per the instructions for use (ifu) / product label.
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Search Alerts/Recalls
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