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

Model Number M00546650

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

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

Event Date 03/19/2021

Event Type  malfunction  

Manufacturer Narrative

(b)(4).The device has been received for analysis.Upon completion of the problem 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 a spyglass ds controller used during the same procedure.It was reported to boston scientific corporation that a spyscope ds ii and a spyglass ds controller were used during a procedure performed on (b)(6) 2021.During the procedure, the image was cutting in and out.They tried using several different scopes, but the 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.

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 y/c video connectors were worn, and the top cover paint and rear bumper was damaged.A functional evaluation noted dust, dirt and lint inside the unit and in the catheter interface contacts preventing a solid connection with the catheter.The light engine was disassembled.The light-emitting diode (led) panel, catheter interface contacts, connector socket assembly, dust and lint throughout the unit were cleaned.The 60mm air intake fans, screen filters, front panel, keypad, y/c video output connectors, top cover, cover gasket and rear bumper 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 dust, dirt and lint found inside the unit and on the catheter interface contacts, thus preventing a solid connection with the catheter.The problem is unlikely related to a manufacturing problem since the unit was manufactured on 19feb2015 which indicates that the issue would have presented in earlier procedures if the cause was traced to a manufacturing problem.A risk review confirms this is not a new or unanticipated event.During a device history record review conducted by enercon it was confirmed that the device met all manufacturing specifications.Based on all gathered information, the most probable root cause of this event 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 a spyglass ds controller used during the same procedure.It was reported to boston scientific corporation that a spyscope ds ii and a spyglass ds controller were used during a procedure performed on (b)(6) 2021.During the procedure, the image was cutting in and out.They tried using several different scopes, but the 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.

• 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: 11648361
• MDR Text Key: 248032634
• Report Number: 3005099803-2021-01644
• Device Sequence Number: 1
• Product Code: NTN
• UDI-Device Identifier: 08714729874348
• UDI-Public: 08714729874348
• 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: 06/22/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/12/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: M00546650
• Device Catalogue Number: 4665
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/29/2021
• Date Manufacturer Received: 05/27/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1