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

Model Number M0054665R0

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

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

Event Date 11/17/2021

Event Type  malfunction  

Event Description

Note: this report pertains to the spyscope ds and spyglass ds controller used during the same procedure.It was reported to boston scientific corporation that a spyscope ds and a spyglass ds controller were used during a cholangioscopy procedure performed in the common bile duct on (b)(6) 2021.During preparation, they saw an interference in the image after 3 minutes of using the spyglass.They connected again the spyscope but half of the image in the screen was ok and the other half had lines and colors, so they couldn't see the video properly.The procedure was not completed due to this event.There were no patient complications reported as a result of this event.

Manufacturer Narrative

(b)(4).The device has not been received for analysis.Upon receipt and 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 the spyscope ds and spyglass ds controller used during the same procedure.It was reported to boston scientific corporation that a spyscope ds and a spyglass ds controller were used during a cholangioscopy procedure performed in the common bile duct on november 17, 2021.During preparation, they saw an interference in the image after 3 minutes of using the spyglass.They connected again the spyscope but half of the image in the screen was ok and the other half had lines and colors, so they couldn't see the video properly.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 (impact codes): impact code f1001 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 no defects, wear and tear or damaged.No functional problems found with this controller.No errors in the error log.The reported event was not confirmed.A risk review confirms this is not a new or unanticipated event.A device history record review conducted by the enercon confirmed that the device met all manufacturing specifications.Based on gathered information, the most probable root cause selected is no problem detected.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.

• Brand Name: SPYGLASS DS
• Type of Device: LED LIGHT SOURCE
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• Manufacturer (Section G): ENERCON TECHNOLOGIES; 25 northbrook dr; 665; gray ME 04039
• Manufacturer Contact: carole morley ; 300 boston scientific way; marlborough, MA 01752 ; 5086834015
• MDR Report Key: 12924414
• MDR Text Key: 286250106
• Report Number: 3005099803-2021-06361
• Device Sequence Number: 1
• Product Code: FBN
• UDI-Device Identifier: 08714729874362
• UDI-Public: 08714729874362
• Combination Product (y/n): N
• Reporter Country Code: SP
• PMA/PMN Number: K142922
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 04/21/2022

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
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/17/2021
• Initial Date FDA Received: 12/03/2021
• Supplement Dates Manufacturer Received: 03/30/2022
• Supplement Dates FDA Received: 04/21/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/01/2019
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1