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

Model Number M0054665Z0

Device Problem Poor Quality Image (1408)

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

Event Date 06/25/2023

Event Type  malfunction  

Manufacturer Narrative

Block h6 (impact codes): imdrf impact code f05 is being used to capture the reportable event of delay to treatment/ therapy.

Event Description

Note: this report pertains to the spyscope ds ii access & delivery catheter and spyglass ds controller used during the same procedure.It was reported to boston scientific corporation that a spyscope ds ii and a spy ds controller were used during an endoscopic retrograde cholangiopancreatography (ercp) with spyglass procedure performed in the bile duct on (b)(6) 2023.During the procedure, the spyscope ds ii and spy ds controller showed no image on the screen.The spyscope ds ii was unplugged and re-plugged from the spyglass ds controller; however, no image was displayed.The procedure was not completed due to this event.The rescheduled procedure was completed on (b)(6) 2023.There were no reported patient complications as a result of this event.

Manufacturer Narrative

Block h6 (impact codes): imdrf impact code f05 is being used to capture the reportable event of delay to treatment/ therapy.Block h10: investigation results the returned spyglass digital controller was analyzed by enercon technologies, and the evaluation noted that no defects, wear and tear or damage to the spyglass digital controller.Enercon technologies could not produce or confirm any kind of malfunction and no functional problems were found.Per the evaluation conducted by enercon technologies, the reported complaint was not confirmed.Based on all gathered information, the conclusion code selected for this event is no problem detected, which indicates that the device complaint or problem cannot be confirmed.A labeling review was performed and, from the information available, this device was used per the instructions for use (ifu) / product label.Block h11: correction - block d4 (model number and lot number) has been corrected.Correction - block g1 (manufacturer contact first name) has been corrected.

Event Description

Note: this report pertains to the spyscope ds ii access & delivery catheter and spyglass ds controller used during the same procedure.It was reported to boston scientific corporation that a spyscope ds ii and a spy ds controller were used during an endoscopic retrograde cholangiopancreatography (ercp) with spyglass procedure performed in the bile duct on (b)(6) 2023.During the procedure, the spyscope ds ii and spy ds controller showed no image on the screen.The spyscope ds ii was unplugged and re-plugged from the spyglass ds controller; however, no image was displayed.The procedure was not completed due to this event.The rescheduled procedure was completed on (b)(6) 2023.There were no reported patient complications as a result of this event.

• 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: 17371055
• MDR Text Key: 320075990
• Report Number: 3005099803-2023-03735
• Device Sequence Number: 1
• Product Code: NTN
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K142922
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 08/29/2023

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: 4665Z
• Device Lot Number: 1517400052
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/12/2023
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 06/25/2023
• Initial Date FDA Received: 07/21/2023
• Supplement Dates Manufacturer Received: 08/08/2023
• Supplement Dates FDA Received: 08/29/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/23/2015
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1