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

Model Number M0054665R0

Device Problems Optical Problem (3001); Appropriate Term/Code Not Available (3191)

Patient Problems No Consequences Or Impact To Patient (2199); No Known Impact Or Consequence To Patient (2692)

Event Date 06/30/2020

Event Type  malfunction  

Manufacturer Narrative

(b)(4).The device has not been received for analysis.Upon receipt and 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

It was reported to boston scientific corporation that a spyscope ds and a spyglass ds controller were used during an endoscopic retrograde cholangiopancreatography (ercp) procedure performed on (b)(6) 2020.According to the complainant, during procedure, the controller powers on, the front panel button is illuminated but no light connects to the lights on the spyscope ds.A second spysope ds was used; however, there was still no lights coming out.The procedure was not completed due to this event.There were no reported patient complications as a result of this event.

Manufacturer Narrative

Additional information: b5, h6 (patient codes).Block h6 (device codes): problem code 3191 is being used to capture the reportable issue of aborted/cancelled procedure.Block h10: 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

It was reported to boston scientific corporation that a spyscope ds and a spyglass ds controller were used during an endoscopic retrograde cholangiopancreatography (ercp) procedure performed on (b)(6) 2020.According to the complainant, during procedure, the controller powers on, the front panel button is illuminated but no light connects to the lights on the spyscope ds.A second spysope ds was used; however, there was still no lights coming out.The procedure was not completed due to this event.There were no reported patient complications as a result of this event.Additional information 27jul2020: reportedly, there were no patient complications as a result of this event.

Manufacturer Narrative

Additional information: b5, h6 (patient codes).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 controller was analyzed by enercon technologies, and a visual evaluation noted that the video output connections on the back of the unit showed wear damage.The reported event was not confirmed.As per sfmd report, there were no errors in the error log.The light engine required cleaning and calibration.A holding pin on 2 of the led driver card guides were snapped off; however, the driver cards were firmly in place.A risk review confirms this is not a new or unanticipated event, the issue is unlikely related to manufacturing problem since the unit was manufactured on 11may2015 which indicates that the issue would have presented in earlier procedures if the cause was traced to a manufacturing problem.Although the number of procedures/recycles of the unit are unknown, handling during use and reprocessing over time likely contributed to the event.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.

Event Description

It was reported to boston scientific corporation that a spyscope ds and a spyglass ds controller were used during an endoscopic retrograde cholangiopancreatography (ercp) procedure performed on (b)(6) 2020.According to the complainant, during procedure, the controller powers on, the front panel button is illuminated but no light connects to the lights on the spyscope ds.A second spysope ds was used; however, there was still no lights coming out.The procedure was not completed due to this event.There were no reported patient complications as a result of this event.Additional information 27jul2020: reportedly, there were no patient complications as a result of this event.

• Brand Name: SPYGLASS DS
• Type of Device: LED LIGHT SOURCE
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• MDR Report Key: 10308448
• MDR Text Key: 199898495
• Report Number: 3005099803-2020-02914
• Device Sequence Number: 1
• Product Code: FBN
• UDI-Device Identifier: 08714729874362
• UDI-Public: 08714729874362
• 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,Followup
• Report Date: 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
• Device Operator: 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 Manufacturer Received: 06/30/2020
• Initial Date FDA Received: 07/22/2020
• Supplement Dates Manufacturer Received: 07/27/2020; 08/25/2020
• Supplement Dates FDA Received: 08/24/2020; 09/21/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1