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

Model Number	M0054665R0
Medical Device Problem Codes	Failure to Power Up (1476); Appropriate Device Problem Term/Code Not Available (3191)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	07/13/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(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 or Problem Description
It was reported to boston scientific corporation that a spyglass ds controller was used during an endoscopic retrograde cholangiopancreatography (ercp) procedure performed in the common bile duct on (b)(6) 2020.According to the complainant, during the procedure, it was noticed that there was no light source coming from the spyglass ds controller.The controller would come on for a second then go dormant.Reportedly, the controller was rebooted; however, there was still no light source coming from the controller.All connections were checked including the outlets which worked with other devices.The procedure was rescheduled 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 ok.
Event or Problem Description
It was reported to boston scientific corporation that a spyglass ds controller was used during an endoscopic retrograde cholangiopancreatography (ercp) procedure performed in the common bile duct on (b)(6) 2020.According to the complainant, during the procedure, it was noticed that there was no light source coming from the spyglass ds controller.The controller would come on for a second then go dormant.Reportedly, the controller was rebooted; however, there was still no light source coming from the controller.All connections were checked including the outlets which worked with other devices.The procedure was rescheduled 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 ok.
Additional Manufacturer Narrative
Block h6 (device codes): problem code 3191 is being used to capture the reportable issue of aborted/cancelled procedure.Block h10: the returned spyglass ds digital controller was analyzed by enercon technologies.The analysis found that the top cover and bottom chassis have scratches and front panel cosmetic damage.A functional assessment was performed and fluid ingress was present.The socket, retention tongue and catheter interface printed circuit board (pcb) were all found to be damaged.The reported event was confirmed.It is likely that the issue was caused by fluid ingress to the console causing damage to the pcb board catheter interface which is normally caused by poor or inappropriate reprocessing, as per supplier report a series of components were replaced as a regular maintenance precaution.Although the number of procedures/recycles of the unit are unknown, handling during use and reprocessing over time likely contributed to the event.A risk review confirms this is not a new or unanticipated event, the issue is unlikely related to manufacturing problem, the unit was manufactured in (b)(6) 2015 which indicates that the issue would have presented in earlier procedures if the cause was traced to a manufacturing problem.Based on all gathered information, the most probable root cause of this 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.

• Brand Name: SPYGLASS DS
• Common Device Name: LED LIGHT SOURCE
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• MDR Report Key: 10387155
• Report Number: 3005099803-2020-03099
• Device Sequence Number: 13922060
• Product Code: FBN
• UDI-Device Identifier: 08714729874362
• UDI-Public: 08714729874362
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: K142922
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 09/21/2020

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
• Operator of Device: Health Professional
• Device Model Number: M0054665R0
• Device Catalogue Number: 4665R
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/03/2020
• Initial Date Received by Manufacturer: 07/13/2020
• Supplement Date Received by Manufacturer: 08/28/2020
• Initial Report FDA Received Date: 08/10/2020
• Supplement Report FDA Received Date: 09/21/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1