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

Model Number	M0054665R0
Medical Device Problem Codes	Poor Quality Image (1408); Appropriate Device Problem Term/Code Not Available (3191)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	11/17/2020
Type of Reportable Event	Malfunction
Additional 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 or Problem Description
It was reported to boston scientific corporation that a spy ds controller was used during an endoscopic retrograde cholangiopancreatography (ercp) procedure performed in the bile duct on (b)(6) 2020.According to the complainant, during the procedure, the image displayed a gray box even though the controller power was on.The spyscope was connected and no image was displayed.Reportedly, the spyscope ds was switched out for another spyscope ds; however, the image problem was not resolved.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
• Common Device Name: LED LIGHT SOURCE
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• MDR Report Key: 10968079
• Report Number: 3005099803-2020-05945
• Device Sequence Number: 17185752
• Product Code: FBN
• UDI-Device Identifier: 08714729874362
• UDI-Public: 08714729874362
• Combination Product (Y/N): N
• Initial Reporter State: TN
• 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
• Report Date (Section B): 12/08/2020

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?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/17/2020
• Initial Report FDA Received Date: 12/08/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1