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

Model Number M0054665Z0

Device Problems Failure to Power Up (1476); Optical Problem (3001)

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

Event Date 03/06/2023

Event Type  malfunction  

Manufacturer Narrative

Block h6 (impact codes): impact code f1001 is being used to capture the reportable event of aborted/cancelled procedure.

Event Description

Note: this report pertains to two spyscope ds ii access & delivery catheters and a spyglass ds - digital controller that were used in the same patient and procedure.It was reported to boston scientific corporation that two spyscopes ds ii and a spyglass ds controller were used during an endoscopic retrograde cholangiopancreatography (ercp) procedure performed on (b)(6) 2023.During the procedure, the image cannot be displayed.The procedure was not completed due to this event.There were no patient complications reported as a result of this event.

Event Description

Note: this report pertains to two spyscope ds ii access & delivery catheters and a spyglass ds - digital controller that were used in the same patient and procedure.It was reported to boston scientific corporation that two spyscopes ds ii and a spyglass ds controller were used during an endoscopic retrograde cholangiopancreatography (ercp) procedure performed on (b)(6) 2023.During the procedure, the image cannot be displayed.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 h11: block d4 serial number has been corrected.Block d4 model number and block h6 device codes have been updated based on additional information received on 25apr2023.

• Brand Name: SPYGLASS DS DIGITAL CONTROLLER
• 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: 16678006
• MDR Text Key: 313558483
• Report Number: 3005099803-2023-01578
• Device Sequence Number: 1
• Product Code: NTN
• UDI-Device Identifier: 08714729874348
• UDI-Public: 08714729874348
• Combination Product (y/n): N
• Reporter Country Code: HK
• 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: 05/15/2023

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: M0054665Z0
• Device Catalogue Number: 4665
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/06/2023
• Initial Date FDA Received: 04/04/2023
• Supplement Dates Manufacturer Received: 04/18/2023
• Supplement Dates FDA Received: 05/15/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/01/2015
• 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