MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION SPYGLASS DS DIGITAL CONTROLLER; LED LIGHT SOURCE

Model Number M0054665Z0

Device Problems Poor Quality Image (1408); Appropriate Term/Code Not Available (3191)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 03/01/2021

Event Type  malfunction  

Manufacturer Narrative

The exact date of the event is unknown.The provided event date (b)(6) 2021 was chosen as a best estimate based on the date that the manufacturer became aware of the event.(b)(4).The device has been received for analysis; however, the analysis has not yet been completed.Upon completion of the failure analysis of the complaint device, if there is any further relevant information from that review, a supplemental medwatch will be filed.

Event Description

Note: this report pertains to a spyscope ds ii and spyglass ds controller used during the same procedure.It was reported to boston scientific corporation that a spyscope ds ii and spyglass ds controller were used during a cholangioscopy procedure performed in the common bile duct (cbd) on an unknown date.During the procedure, the monitor showed grey and a distorted image.The spyglass ds controller was rebooted but the problem was not resolved.An autolith electrohydraulic lithotripsy (ehl) probe was used when the visualization problem occurred.The procedure was not completed due to this event.There were no patient complications reported as a result of this event.The patient's condition at the conclusion of the procedure was reported to be fine.

Manufacturer Narrative

Block b3 (date of event): the exact date of the event is unknown.The provided event date (b)(6) 2021 was chosen as a best estimate based on the date that the manufacturer became aware of the event.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.Upon analysis, there was contamination on catheter interface contacts and parts were wearing and tearing, which could cause bad connection.After cleaning and replacing parts, the device was returned to use.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.

Event Description

Note: this report pertains to a spyscope ds ii and spyglass ds controller used during the same procedure.It was reported to boston scientific corporation that a spyscope ds ii and spyglass ds controller were used during a cholangioscopy procedure performed in the common bile duct (cbd) on an unknown date.During the procedure, the monitor showed grey and a distorted image.The spyglass ds controller was rebooted but the problem was not resolved.An autolith electrohydraulic lithotripsy (ehl) probe was used when the visualization problem occurred.The procedure was not completed due to this event.There were no patient complications reported as a result of this event.The patient's condition at the conclusion of the procedure was reported to be fine.

• Brand Name: SPYGLASS DS DIGITAL CONTROLLER
• Type of Device: LED LIGHT SOURCE
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• MDR Report Key: 11641055
• MDR Text Key: 248027541
• Report Number: 3005099803-2021-01631
• Device Sequence Number: 1
• Product Code: NTN
• Combination Product (y/n): N
• PMA/PMN Number: K142922
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 07/12/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: M0054665Z0
• Device Catalogue Number: 4665Z
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/06/2021
• Initial Date Manufacturer Received: 03/19/2021
• Initial Date FDA Received: 04/09/2021
• Supplement Dates Manufacturer Received: 06/17/2021
• Supplement Dates FDA Received: 07/12/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1