Model Number M0054665Z0 |
Device Problems
Optical Problem (3001); Appropriate Term/Code Not Available (3191)
|
Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
|
Event Date 03/17/2021 |
Event Type
malfunction
|
Manufacturer Narrative
|
(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 mdr will be filed.
|
|
Event Description
|
Note: this report pertains to the two spyscope ds ii, spysnare and spyglass ds controller used during the same procedure.It was reported to boston scientific corporation that the two spyscope ds ii, spysnare and spyglass ds controller were used during a cholangioscopy procedure performed in the common bile duct (cbd) on (b)(6) 2021.During the procedure, the image of the first spyscope ds ii was lost less than 5 minutes into the procedure.A second spyscope ds ii was used, however, the image was also lost.An autolith electrohydraulic lithotripsy (ehl) probe was used when the visualization problems occurred.The spyscope ds ii was disconnected and reconnected back to the controller, and the controller was rebooted several times; however, the problem was not resolved.They also tried to used a spysnare, and it failed to open when it was inside the scope and inside the patient.The procedure was rescheduled due to this event.There were no patient complications reported as a result of this event.
|
|
Event Description
|
Note: this report pertains to the two spyscope ds ii, spysnare and spyglass ds controller used during the same procedure.It was reported to boston scientific corporation that the two spyscope ds ii, spysnare and spyglass ds controller were used during a cholangioscopy procedure performed in the common bile duct (cbd) on (b)(6) 2021.During the procedure, the image of the first spyscope ds ii was lost less than 5 minutes into the procedure.A second spyscope ds ii was used, however, the image was also lost.An autolith electrohydraulic lithotripsy (ehl) probe was used when the visualization problems occurred.The spyscope ds ii was disconnected and reconnected back to the controller, and the controller was rebooted several times; however, the problem was not resolved.They also tried to used a spysnare, and it failed to open when it was inside the scope and inside the patient.The procedure was rescheduled due to this event.There were no patient complications reported as a result of this event.
|
|
Manufacturer Narrative
|
Block h6 (device codes): medical device problem code a27 is being used to capture the reportable event of aborted/cancelled procedure.Block h10: the returned spyglass ds digital controller was analyzed by enercon technologies, and a visual evaluation noted that the top cover and front panel had stickers all over.A functional evaluation noted that the catheter interface contacts required cleaning.The y/c video outputs were worn.The light engine was disassembled.The catheter interface contacts and connector socket assembly were cleaned.The y/c video output connectors, front panel, keypad, flex cable, rear bumper, top cover and cover gasket were replaced.Light engine calibration was performed and a test was ran.An electrical safety test was performed and the unit passed all tests.The reported event was confirmed.The damaged components were replaced and cleaned, and the unit passed all tests.Based on all gathered information, the most probable root cause of this event complaint is cause traced to maintenance.A review of the manufacturing documentation for this device revealed that no anomalies or deviations related to the event occurred during manufacturing.A search of the complaint database confirmed that no similar complaint exist for the specified lot.
|
|
Search Alerts/Recalls
|
|