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

Model Number M0054665Z0

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

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

Event Date 10/13/2021

Event Type  malfunction  

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 ii catheter and spyglass ds digital controller used during the same procedure.It was reported to boston scientific corporation that a spyscope ds ii catheter and spyglass ds digital controller were used during cholangioscopy procedure performed in the gallbladder on (b)(6) 2021.During the procedure, the image of the spyscope ds ii catheter was intermittent.The image came on and then disappear.Sometimes, it showed dots, prompt to plug in the spyscope; other times, it was just black.They tried unplugging the spyscope catheter and reinserted back into the controller and this would work temporarily.They tried to test it with demo a scope and the picture was intermittent as well.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 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.Block h11: blocks e1, e2, and e3 have been updated based on additional information received november 08, 2021.

Event Description

Note: this report pertains to the spyscope ds ii catheter and spyglass ds digital controller used during the same procedure.It was reported to boston scientific corporation that a spyscope ds ii catheter and spyglass ds digital controller were used during cholangioscopy procedure performed in the gallbladder on (b)(6) 2021.During the procedure, the image of the spyscope ds ii catheter was intermittent.The image came on and then disappear.Sometimes, it showed dots, prompt to plug in the spyscope; other times, it was just black.They tried unplugging the spyscope catheter and reinserted back into the controller and this would work temporarily.They tried to test it with demo a scope and the picture was intermittent as well.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 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: 12752471
• MDR Text Key: 280192881
• Report Number: 3005099803-2021-05706
• Device Sequence Number: 1
• Product Code: NTN
• Combination Product (y/n): N
• Reporter Country Code: CA
• 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: 11/22/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/04/2021
• 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
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/08/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/08/2017
• 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